Abstract
Introduction
In nuclear medicine, there is a critical need to balance the control and optimization of radiation doses to ensure patient safety while achieving high-quality diagnostic outcomes. However, diagnostic reference levels (DRLs) for nuclear medicine imaging studies have not been established in India. This study aims to fill this gap by establishing institutional DRLs and assessing radiation dose data specifically for Nuclear Medicine SPECT examinations.
Methods
This research was a cross-sectional observational study conducted in a single tertiary care setting, involving 1,250 patients. Data on the administered activity for 18 common single photon emission computed tomography (SPECT) procedures were gathered from 2019 to 2021. The 75th percentile (Q3) was established as the baseline for the institutional DRLs. Furthermore, the study conducted comparative analyses with established international DRLs.
Results
The study proposed institutional DRLs based on 18 SPECT nuclear medicine imaging examinations. The highest Q3 DRLs were identified for 99mTc-sestamibi (1193 MBq), followed by 99mTc-methylene diphosphonate (747 MBq) and 99mTc-ethyl cysteinate dimer (608 MBq). The lowest DRL was recorded for 99mTc gastric emptying imaging (37 MBq). Comparisons with international DRLs indicated close alignment with European Association of Nuclear Medicine Medical Internal Radiation Dose guidelines, while DRLs set by the National Council on Radiation Protection and Measurements (NCRP) were identified as distinct in several key aspects when compared to other established DRLs.
Conclusion
This research marks a significant step toward standardizing SPECT procedure doses in India, contributing to improved patient safety and care in nuclear medicine. The established DRLs will enhance the optimization of administered activities, ensure adherence to international standards, and improve diagnostic quality while reducing radiation exposure. These institutional DRLs will serve as the foundation for developing a roadmap to establish national DRLs.
Keywords: diagnostic reference level, institutional reference level, nuclear medicine, radiation dose, single photon emission computed tomography
Introduction
As per the World Nuclear Association's 2024 reports, over 50 million nuclear procedures are conducted annually, with the demand for radioisotopes rising each year. According to a report published by the Atomic Energy Regulatory Board (AERB) in 2022, nuclear medicine procedures in India have been steadily increasing. As this growth persists, there has been a significant increase in medical radiation exposure for patients, family members, healthcare professionals, and the environment [1]. Although there are no restrictions on patient exposure, it should be reduced to the lowest level technically feasible, considering economic and social factors. Regular monitoring and evaluation of occupational and patient doses are essential to curtail potential radiation risks, including the potential for carcinogenesis [2]. Establishing diagnostic reference levels (DRLs) is a crucial tool for reducing unnecessary medical radiation exposure and addressing social concerns, as well as for optimizing radiation use in imaging. It serves as a reference level for an easily measurable quantity, typically the administered activity in megabecquerels (MBq) in nuclear medicine imaging studies [3]. A common misconception is that the DRL signifies a recommended activity level or a limit, suggesting that higher activities should not be administered. This misunderstanding may arise from variations in the definition of DRL across different guiding documents [4,5]. The earlier European Commission (EC) publication [4] introduced a recommended activity level, while the latest International Commission on Radiological Protection (ICRP) publication suggests using a reference level of doses based on an analysis of local or institutional practices [5]. In India, the first nuclear medicine DRLs for six radiopharmaceuticals were published in the Indian Council of Medical Research (ICMR) bulletin [6]; however, there is still a lack of implementation of the DRL approach in nuclear medicine procedures. Therefore, the goal was to establish the first institutional DRLs for administered activity in single-photon emission computed tomography (SPECT) imaging procedures with ICRP recommendations [5]. This research outlines the process of establishing the first institutional DRLs for SPECT procedures in India. Dose distribution data from various SPECT imaging procedures was analyzed to calculate the 75th percentile (Q3) for establishing the DRLs. Additionally, we compared our findings with those from various international organizations and countries.
Materials and methods
Study design
This research was a single-center, cross-sectional observational study conducted at the All India Institute of Medical Sciences in Rishikesh, India. Data on administered activity (MBq) for radioisotopes 99mTc and I-131 in SPECT procedures were collected from 2019 to 2021. Ethical clearance was obtained from the Institutional Ethics Committee (IEC code: 47/IEC/PhD/2018). The study included 18 common nuclear medicine SPECT procedures: bone imaging, brain imaging, gastric emptying imaging, liver imaging, lung perfusion imaging, lymphoscintigraphy, Meckel's imaging, myocardial perfusion (rest and stress), renal diethylenetriamine pentaacetate (DTPA), renal ethylene dicysteine (EC), renal dimercaptosuccinic acid (DMSA), parathyroid imaging, thyroid imaging, salivary gland imaging, whole-body Iodine (I-131) thyroid imaging, and testicular imaging. Both male and female participants were included to establish institutional DRLs, while pregnant and breastfeeding women were excluded from the study. Equipment details are mentioned in Table 1.
Table 1. SPECT/CT equipment details.
SPECT: Single-Photon Emission Computed Tomography.
| Maximum number of slices | 16 |
| Tube current | 10-440 mA |
| Tube voltage | 80,100,120,140 kVp |
| Scan times | 1920 slices/min |
| Manufacturer name | GE Healthcare Technologies Inc. |
| Model | GE Discovery NM/CT 670 |
| Mode | Dual head variable angle |
Data collection
Data on administered activity in SPECT/CT nuclear medicine imaging studies (GE Discovery NM/CT670) were collected from 1,250 cases using clinical history sheets from 2019 to 2021 and recorded in Microsoft Excel. Only examinations with complete patient information, age, gender, date, dose information, and study description, were included. The study documented the types of exams and the average administered radiopharmaceutical doses for each procedure performed at the institution. Before data collection, equipment calibration and quality control procedures were verified. Incomplete data and missing values were removed.
Statistical analysis
Complete data were analyzed and tabulated using R software (The R Foundation ©, Vienna, Austria) to calculate descriptive statistics, including range, mean, median, mode, interquartile range (Q1, Q2, Q3), and SD. Institutional DRLs were then compared with existing DRLs from other countries and organizations using box plots and heat maps.
Results
Table 2 presents the established institutional DRLs for various imaging procedures, detailing the associated radiopharmaceuticals and their minimum and maximum ranges. It also includes the mean, standard deviation, and the 25th, 50th, and 75th percentiles. To determine the institutional DRLs, we focused on the 75th percentile values across all procedures. The highest 75th percentile values were noted for 99mTc-sestamibi (MIBI) (1193 MBq), 99mTc-methylene diphosphonate (MDP) (747 MBq), and 99mTc-ethyl cysteinate dimer (ECD) (608 MBq), while the lowest was found for 99mTc gastric emptying imaging (37 MBq).
Table 2. DRLs for SPECT/CT nuclear medicine imaging procedures.
SPECT: Single-Photon Emission Computed Tomography; DRL: Diagnostic Reference Level.
| Imaging Procedure | Radiopharmaceuticals | Min | Max | Percentile | Mean | SD | DRLs | ||
| 25th | 50th | 75th | |||||||
| Bone Imaging | 99mTc MDP | 532 | 939 | 674 | 721 | 747 | 707.08 | 71.82 | 747 |
| Brain Imaging | 99mTc ECD | 355 | 610 | 402 | 573 | 608 | 528.17 | 119.1 | 608 |
| Gastric Emptying Imaging | 99mTc Sulphur colloid | 37 | 51.8 | 37 | 37 | 37 | 38.92 | 4.03 | 37 |
| Liver Imaging | 99mTc HIDA | 144 | 188 | 155 | 170 | 177 | 167.29 | 13.16 | 177 |
| Lung Perfusion Imaging | 99mTc MAA | 151 | 200 | 157 | 174 | 197 | 175.93 | 19.84 | 197 |
| Lymphoscintigraphy | 99mTc Nano-colloid | 37 | 52 | 38 | 44 | 50 | 44.4 | 5.85 | 50 |
| Meckel’s Imaging | 99mTc pertechnetate | 181 | 211 | 181 | 192 | 205 | 193.14 | 12.65 | 205 |
| Myocardial Perfusion, stress 1 day | 99mTc MIBI | 309 | 377 | 325 | 342 | 357 | 343.86 | 20.52 | 357 |
| Myocardial Perfusion, rest 1 day | 99mTc MIBI | 476 | 876 | 521 | 577 | 684 | 601.27 | 104.9 | 684 |
| Myocardial Perfusion, stress- rest 1 day | 99mTC MIBI | 825 | 1309 | 1004 | 1121 | 1193 | 1093.9 | 145.5 | 1193 |
| Renal Imaging | 99m Tc EC | 88 | 181 | 133 | 148 | 156 | 142.33 | 20.42 | 156 |
| Renal Imaging | 99m Tc DTPA | 85 | 188 | 146 | 160 | 170 | 155.58 | 22.07 | 170 |
| Renal Imaging | 99m Tc DMSA | 77 | 188 | 160 | 170 | 181 | 159.65 | 36.29 | 181 |
| Parathyroid Imaging | 99mTc MIBI | 392 | 469 | 429 | 455 | 465 | 444.20 | 25.31 | 465 |
| Thyroid Imaging | 99m Tc pertechnetate | 66 | 192 | 129 | 155 | 166 | 146.93 | 30.68 | 166 |
| Salivary Gland Imaging | 99m Tc pertechnetate | 144 | 185 | 148 | 152 | 178 | 161.39 | 16.87 | 178 |
| Whole body I-131 Thyroid Imaging | 131 I | 159 | 410 | 179 | 207 | 327 | 247.9 | 86.43 | 327 |
| Testicular Imaging | 99m Tc pertechnetate | 144 | 196 | 155 | 175 | 192 | 172.05 | 18.84 | 192 |
A box plot displaying the interquartile range and a detailed descriptive statistical summary was created using R software for each imaging procedure (Appendices 1-2). The plot shows data distribution, including median values, the spread of the data within the interquartile range, and outliers. The 75th percentile DRL, indicating the upper quartile of the data, is also prominently shown in Figures 1-2, thus offering a clear visual representation of the variation across the samples.
Figure 1. Distribution of institutional DRLs interquartile range showing 75th percentile.
DRL: Diagnostic Reference Level.
Figure 2. Distribution of institutional DRLs interquartile range showing 75th percentile.
DRL: Diagnostic Reference Level.
In Table 3, the study compared the institutional DRLs in India with those from international organizations, including Basic Safety Standards (BSS), Society of Nuclear Medicine and Molecular Imaging (SNMMI), European Association of Nuclear Medicine Medical Internal Radiation Dose (EANMMI), National Council on Radiation Protection and Measurements (NCRP), and the European Union (EU). Institutional DRLs were also compared with those from Asian countries (Table 4), African countries (Table 5), European countries, and Australia (Table 6). To visualize the comparison of DRLs across different countries and organizations, the study utilized both a heatmap and a boxplot (Figure 3).
Table 3. Comparison of institutional DRL with international organizations.
DRL: Diagnostic Reference Level; I-DRL: Institutional Diagnostic Reference Levels; EU: European Union; NCRP: National Council on Radiation Protection and Measurements; EANMMI: European Association of Nuclear Medicine Medical Internal Radiation Dose; SNMMI: Society of Nuclear Medicine and Molecular Imaging; BSS: Basic Safety Standards; 99mTc MDP: 99mTc Methylene Diphosphonate; 99mTc ECD: 99mTc Ethyl Cysteinate Dimer; 99mTc HIDA: 99mTc Hepatobiliary Iminodiacetic Acid.
| Imaging Procedure | Radiopharmaceuticals | Proposed I-DRL | BSS [7] | SNMMI [8] | EANMMI [9] | NCRP [10] | EU [4] |
| Bone Imaging | 99mTc MDP | 747 | 600 | 740-1110 | 500 | 848-1185 | 500-1100 |
| Brain Imaging | 99mTc ECD | 608 | 887-1294 | ||||
| Gastric Emptying Imaging | 99mTc Sulphur colloid | 37 | 40 | 18.5-37 | 40 | ||
| Liver Imaging | 99mTc HIDA | 177 | |||||
| Lung Perfusion Imaging | 99mTc MAA | 197 | 100 | 40-150 | 79 | 147-226 | 100-296 |
| Lymphoscintigraphy | 99mTc Nano-colloid | 50 | |||||
| Meckel’s Imaging | 99mTc pertechnetate | 205 | |||||
| Myocardial Perfusion, stress 1 day | 99mTc MIBI | 357 | |||||
| Myocardial Perfusion, rest 1 day | 99mTc MIBI | 684 | |||||
| Myocardial Perfusion, stress - rest 1 day | 99mTC MIBI | 1193 | |||||
| Renal Imaging | 99m Tc EC | 156 | |||||
| Renal Imaging | 99m Tc DTPA | 170 | 350 | 37-370 | 200 | 407-587 | |
| Renal Imaging | 99m Tc DMSA | 181 | 160 | 11-110 | 97 | 189-289 | 70-183 |
| Parathyroid Imaging | 99mTc MIBI | 465 | |||||
| Thyroid Imaging | 99m Tc pertechnetate | 166 | 200 | 74-370 | 80 | 75-222 | |
| Salivary Gland Imaging | 99m Tc pertechnetate | 178 | 40 | 185-370 | 185-370 | ||
| Whole body I-131 Low-dose Thyroid Imaging | 131 I | 327 | 400 | 37-185 | 10-185 | 90-400 | |
| Testicular Imaging | 99m Tc pertechnetate | 192 |
Table 4. Comparison of institutional DRL with Asian countries.
DRL: Diagnostic Reference Level; I-DRL: Institutional Diagnostic Reference Levels; 99mTc MDP: 99mTc Methylene Diphosphonate; 99mTc ECD: 99mTc Ethyl Cysteinate Dimer; 99mTc HIDA: 99mTc Hepatobiliary Iminodiacetic Acid; 99mTc MAA: 99mTc Macroaggregated Albumin.
| Imaging Procedure | Radiopharmaceuticals | Proposed I-DRL | Korea [11] | Japan [12] |
| Bone Imaging | 99mTc MDP | 747 | 925 | 950 |
| Brain Imaging | 99mTc ECD | 608 | 925 | 800 |
| Gastric Emptying Imaging | 99mTc Sulphur colloid | 37 | 111 | |
| Liver Imaging | 99mTc HIDA | 177 | ||
| Lung Perfusion Imaging | 99mTc MAA | 197 | 222 | 260 |
| Lymphoscintigraphy | 99mTc Nano-colloid | 50 | ||
| Meckel’s Imaging | 99mTc pertechnetate | 205 | ||
| Myocardial Perfusion, stress 1 day | 99mTc MIBI | 357 | ||
| Myocardial Perfusion, rest 1 day | 99mTc MIBI | 684 | ||
| Myocardial Perfusion, stress- rest 1 day | 99mTC MIBI | 1193 | 555-1110 | 900-1200 |
| Renal Imaging | 99m Tc EC | 156 | ||
| Renal Imaging | 99m Tc DTPA | 170 | 555 | 400 |
| Renal Imaging | 99m Tc DMSA | 181 | 185 | 210 |
| Parathyroid Imaging | 99mTc MIBI | 465 | 740 | 800 |
| Thyroid Imaging | 99m Tc pertechnetate | 166 | 217 | 300 |
| Salivary Gland Imaging | 99m Tc pertechnetate | 178 | 370 | 370 |
| Whole body I-131 low dose Thyroid Imaging | 131 I | 327 | 185 | |
| Testicular Imaging | 99m Tc pertechnetate | 192 |
Table 5. Comparison of institutional DRL with African countries.
DRL: Diagnostic Reference Level; I-DRL: Institutional Diagnostic Reference Levels; 99mTc MDP: 99mTc Methylene Diphosphonate; 99mTc ECD: 99mTc Ethyl Cysteinate Dimer; 99mTc HIDA: 99mTc Hepatobiliary Iminodiacetic Acid; 99mTc MAA: 99mTc Macroaggregated Albumin.
| Imaging Procedure | Radiopharmaceuticals | Proposed I-DRL | Sudan [13] | Brazil [14] |
| Bone Imaging | 99mTc MDP | 747 | 777 | 1110 |
| Brain Imaging | 99mTc ECD | 608 | - | 1203 |
| Gastric Emptying Imaging | 99mTc Sulphur colloid | 37 | - | 37-60 |
| Liver Imaging | 99mTc HIDA | 177 | 333 | |
| Lung Perfusion Imaging | 99mTc MAA | 197 | ||
| Lymphoscintigraphy | 99mTc Nano-colloid | 50 | ||
| Meckel’s Imaging | 99mTc pertechnetate | 205 | 555 | |
| Myocardial Perfusion, stress 1 day | 99mTc MIBI | 357 | ||
| Myocardial Perfusion, rest 1 day | 99mTc MIBI | 684 | ||
| Myocardial Perfusion, stress- rest 1 day | 99mTC MIBI | 1193 | 740 | 870-925 |
| Renal Imaging | 99m Tc EC | 156 | ||
| Renal Imaging | 99m Tc DTPA | 170 | 206 | 449 |
| Renal Imaging | 99m Tc DMSA | 181 | 173 | 185 |
| Parathyroid Imaging | 99mTc MIBI | 465 | 555 | 740 |
| Thyroid Imaging | 99m Tc pertechnetate | 166 | 185 | 444 |
| Salivary Gland Imaging | 99m Tc pertechnetate | 178 | 555 | |
| Whole body I-131 low dose Thyroid Imaging | 131 I | 327 | ||
| Testicular Imaging | 99m Tc pertechnetate | 192 |
Table 6. Comparison of institutional DRL with European countries and Australia.
DRL: Diagnostic Reference Level; I-DRL: Institutional Diagnostic Reference Levels; 99mTc MDP: 99mTc Methylene Diphosphonate; 99mTc ECD: 99mTc Ethyl Cysteinate Dimer; 99mTc HIDA: 99mTc Hepatobiliary Iminodiacetic Acid; 99mTc MAA: 99mTc Macroaggregated Albumin.
| Imaging Procedure | Radiopharmaceuticals | Proposed I-DRL | Australia [15] | United Kingdom [16] |
| Bone Imaging | 99mTc MDP | 747 | 920 | 600 |
| Brain Imaging | 99mTc ECD | 608 | 750 | 750 |
| Gastric Emptying Imaging | 99mTc Sulphur colloid | 37 | ||
| Liver Imaging | 99mTc HIDA | 177 | ||
| Lung Perfusion Imaging | 99mTc MAA | 197 | 240 | 100 |
| Lymphoscintigraphy | 99mTc Nano-colloid | 50 | ||
| Meckel’s Imaging | 99mTc pertechnetate | 205 | ||
| Myocardial Perfusion, stress 1 day | 99mTc MIBI | 357 | ||
| Myocardial Perfusion, rest 1 day | 99mTc MIBI | 684 | ||
| Myocardial Perfusion, stress- rest 1 day | 99mTC MIBI | 1193 | 620-1520 | 800 |
| Renal Imaging | 99m Tc EC | 156 | ||
| Renal Imaging | 99m Tc DTPA | 170 | 500 | 300 |
| Renal Imaging | 99m Tc DMSA | 181 | 200 | 80 |
| Parathyroid Imaging | 99mTc MIBI | 465 | 900 | 900 |
| Thyroid Imaging | 99m Tc pertechnetate | 166 | 215 | 80 |
| Salivary Gland Imaging | 99m Tc pertechnetate | 178 | 200 | 80 |
| Whole body I-131 Low-dose Thyroid Imaging | 131 I | 327 | 185 | 400 |
| Testicular Imaging | 99m Tc pertechnetate | 192 |
Figure 3. a) Box plot representation of institutional DRLs with international organizations and countries, showing the 75th percentile interquartile range. b) Heat map representing the overall DRL pattern, where a darker region indicates a higher dose pattern in which Institutional DRL (this study) matches with EANMMI, Sudan, BSS, and the United Kingdom, forming one group with similar DRLs, while SNMMI, Brazil, the EU, Australia, Korea, and Japan formed another. The NCRP society remained distinct.
DRL: Diagnostic Reference Level; EANMMI: European Association of Nuclear Medicine Medical Internal Radiation Dose; BSS: Basic Safety Standards; SNMMI: Society of Nuclear Medicine and Molecular Imaging; EU: European Union; NCRP: National Council on Radiation Protection and Measurements.
Discussion
In nuclear medicine, the quality of diagnostic outcomes is closely tied to the administered activity of radiopharmaceuticals, which directly impacts both image quality and patient radiation dose. Administered activity varies depending on the type of single-photon emission procedure and the radiopharmaceutical used. Different procedures, such as bone scans with 99mTc-MDP or myocardial perfusion imaging with 99mTc-MIBI, require tailored doses to produce clear images of specific organs or systems. Each radiopharmaceutical has unique properties that determine the optimal dose to ensure sufficient target uptake while minimizing radiation to non-target tissues. Balancing image quality with radiation safety is crucial, and this is guided by the 'as low as reasonably achievable' (ALARA) principle [17], which aims to minimize exposure without compromising diagnostic efficacy. DRLs are used to standardize and optimize dose patterns, ensuring patient safety while maintaining high diagnostic standards across various nuclear medicine procedures.
This study marks the first attempt to standardize dose patterns for nuclear medicine SPECT procedures at a national level in a tertiary care setting in India. Such standardization is vital for optimizing the administered activity levels in various nuclear medicine techniques, ultimately aiding in the reduction and monitoring of dose patterns. Comparing DRLs from this study with international standards is essential, as differences in dose levels could affect patient health.
DRLs were established at the institutional level for various SPECT nuclear medicine modalities and compared with those from other countries and organizations. Following ICRP guidelines [5], the 75th percentile was used to determine these DRLs. The data, including the mean, median, interquartile range, and DRL values for the administered activity, are presented in Table 2, with comparisons illustrated using box plots (Figures 1-2).
The study revealed the highest dose levels in 99mTc MIBI (methoxy isobutyl isonitrile) stress and rest examinations (1193 MBq), followed by 99mTc MDP (747 MBq) and 99mTc ECD (608 MBq). These procedures require higher administered activities to ensure sufficient radiopharmaceutical uptake in large, metabolically active areas (e.g., the heart, bones, or brain). These procedures often target tissues or organs with significant blood flow or metabolic activity, where a higher dose is necessary to produce clear, high-quality images. For example, myocardial perfusion imaging (MIBI) requires high doses to distinguish subtle differences in blood flow between rest and stress conditions in the heart [18]. Bone imaging was the most common procedure performed at this institute, while myocardial perfusion [19] is notable in Iran. On the other hand, procedures like 99mTc gastric emptying (37 MBq) and 99mTc lymphoscintigraphy (50 MBq) involve organs or processes with lower radiopharmaceutical uptake or slower movement through the body. These procedures require less radiopharmaceutical activity because the diagnostic objective can be achieved with lower radiation exposure, given that the stomach and lymphatic system need only minimal tracer amounts to provide clear imaging. Additionally, these areas often involve slower physiological processes, meaning that lower doses are sufficient to produce diagnostic results over time. Procedures such as liver, renal, and parathyroid imaging fall between these extremes, requiring moderate dose levels. These organs are not as metabolically active as the heart or brain but still need a sufficient dose for clear imaging, especially in assessing function or abnormalities. Thus, the variation in dose levels reflects the need to balance image quality with radiation safety, tailoring the administered activity based on the organ's characteristics, the radiopharmaceutical behavior, and the specific diagnostic requirements of the procedure [20].
A heatmap and boxplot were used to compare DRLs across various countries (Figure 3). The boxplot showed the DRL distribution for each country, highlighting the interquartile range with the 75th percentile for comparison. The heatmap used darker colors to represent higher DRL values, offering a visual comparison. This analysis found that the DRLs from the current study align closely with those of the EANMMI society. Additionally, the NCRP society's DRLs were found to be unique. Japan and Korea displayed similar DRL patterns, as did Australia and the EU. It has been previously demonstrated that Korea adheres to ICRP guidelines [21], and it was found that Japan adheres to SNMMI and EU guidelines [22]. Brazil’s DRLs matched those of SNMMI, while the United Kingdom and BSS showed similarities, with Sudan partially aligning with these groups.
Overall, the study identified two major clusters: India (this study), EANMMI, Sudan, BSS, and the United Kingdom formed one group with similar DRLs, while SNMMI, Brazil, the EU, Australia, Korea, and Japan formed another. The NCRP society remained distinct in a separate cluster (Figure 3).
The EANMMI sets guidelines and standards for nuclear medicine procedures across Europe, emphasizing the safe and effective use of radiopharmaceuticals for both diagnostic and therapeutic purposes. Their recommendations focus on DRLs, radiation dose optimization, and patient safety, aligning with international standards such as those from the IAEA and the ICRP. The inclusion of EANMMI guidelines ensures accurate dosimetry calculations, helping optimize patient radiation exposure while maintaining high diagnostic quality, particularly in SPECT and positron emission tomography (PET) procedures. The alignment of the present study’s DRLs with those of the EANMMI society indicates adherence to European practices, which are recognized for their rigorous standards of radiation protection and patient care [22].
On the other hand, the NCRP sets DRLs specific to United States (US) practices, focusing on optimizing radiopharmaceutical doses for procedures like SPECT and PET while maintaining high diagnostic standards. The uniqueness of the NCRP DRLs can be attributed to the US's specific radiation safety culture, the use of various radiopharmaceuticals, and differences in procedural protocols, leading to its overall differences when compared with international standards like those from the EANM or IAEA [23].
The SNMMI, another renowned US-based organization, also establishes DRLs and guidelines to advance nuclear medicine and molecular imaging. Like the NCRP, the SNMMI prioritizes lowering patient radiation doses while ensuring the validity of diagnostic procedures involving radiopharmaceuticals [8].
Lastly, the BSS, developed by organizations like the IAEA and the WHO, provides globally recognized guidelines that target justification, optimization, and dose limitation to ensure safe radiation use in nuclear medicine [24]. By adhering to these principles, the study contributes to translational efforts to optimize radiation safety and align closely with EANMMI standards. These international comparisons of DRLs emphasize the study’s commitment to maintaining high levels of patient safety and care across various nuclear medicine practices globally.
The limitations of this study include that it was carried out in a single tertiary care setting, which may not represent the variations present in different healthcare settings at the national level. Besides comparisons made with international DRLs, differences in patient demographics, clinical practices, and equipment may influence the observed dose patterns. Institutional DRLs will function as practical models that aid in the development of national DRLs.
Conclusions
This study proposed the first institutional DRLs for 18 SPECT nuclear medicine studies in India at the tertiary care level. This research represents a significant step toward establishing standardized DRLs for nuclear medicine procedures in India, facilitating a standard for radiation dose optimization in a tertiary care setting. By analyzing 18 common nuclear medicine procedures and comparing the DRLs with international standards from societies such as EANMMI, NCRP, and SNMMI, the research highlights key radiation dose variations and aligns India’s practices with global radiation safety frameworks. The findings emphasize the need for continued dose monitoring and optimization, particularly for high-dose procedures like 99mTc MIBI stress and rest examinations, while reinforcing patient safety in lower-dose procedures such as 99mTc gastric emptying and lymphoscintigraphy. The establishment of these DRLs, aligned with international guidelines from the EANMMI, IAEA, and ICRP, provides a robust foundation for future dose regulation, ensuring safe and effective nuclear medicine practices in India and supporting the global discourse on radiation protection.
Acknowledgments
The authors would like to express their gratitude to the All India Institute of Medical Sciences, Rishikesh, the Indian Institute of Technology Roorkee, and the Sanjay Gandhi Post Graduate Institute of Medical Sciences for their valuable support and contributions to this study.
Appendices
Appendix 1
Table 7. Descriptive statistics of various imaging procedures.
| Imaging Procedure | Min. | Q1 | Median | Mean | Q3 | Max. |
| Bone | 268.2 | 540.2 | 703.0 | 639.2 | 740.0 | 939.8 |
| Gastric emptying | 37.00 | 37.00 | 37.00 | 38.00 | 37.00 | 51.80 |
| EC | 88.8 | 133.4 | 148.2 | 142.3 | 156.5 | 181.3 |
| DTPA | 85.1 | 146.8 | 160.0 | 155.6 | 170.2 | 188.7 |
| Brain | 355.2 | 496.7 | 573.5 | 528.2 | 605.0 | 610.5 |
| DMSA | 77.7 | 166.8 | 170.6 | 159.7 | 181.3 | 188.7 |
| HIDA | 144.3 | 155.8 | 170.2 | 167.3 | 176.9 | 188.7 |
| I-131 | 159.1 | 185.0 | 207.2 | 247.9 | 306.2 | 410.7 |
| Lymphoscintigraphy | 37.0 | 40.7 | 44.4 | 44.4 | 48.1 | 51.8 |
| MAA | 151.7 | 161.1 | 174.3 | 175.9 | 192.4 | 200.2 |
| Meckels | 181.3 | 181.3 | 192.4 | 193.1 | 199.8 | 210.9 |
| Rest | 476.9 | 538.4 | 577.2 | 601.3 | 651.2 | 876.9 |
| Parathyroid | 392.2 | 429.9 | 455.1 | 444.2 | 463.2 | 469.9 |
| Salivary Gland | 144.3 | 152.4 | 152.4 | 161.4 | 172.8 | 185.0 |
| Thyroid | 66.6 | 129.5 | 155.4 | 146.9 | 166.5 | 192.4 |
| Testicular | 144.3 | 159.8 | 175.4 | 172.1 | 184.4 | 196.1 |
| Stress | 309.7 | 328.7 | 343.0 | 343.9 | 355.6 | 377.4 |
| Stress and rest | 268.2 | 540.2 | 703.0 | 639.2 | 740.0 | 939.8 |
Appendix 2
Table 8. Descriptive statistics of various countries and organizations' DRL.
DRL: Diagnostic reference level; I-DRL: Institutional Diagnostic Reference Levels; BSS: Basic Safety Standards; SNMMI: Society of Nuclear Medicine and Molecular Imaging; EANMMI: European Association of Nuclear Medicine Medical Internal Radiation Dose; NCRP: National Council on Radiation Protection and Measurements; EU: European Union.
| Imaging Procedure | Min. | Q1 | Median | Mean | Q3 | Max. |
| Proposed I-DRL | 37.0 | 171.8 | 194.5 | 338.3 | 438.0 | 1193.0 |
| Korea | 111.0 | 201.0 | 370.0 | 504.1 | 832.5 | 1110.0 |
| Japan | 210.0 | 300.0 | 400.0 | 587.8 | 800.0 | 1200.0 |
| Australia | 185.0 | 203.8 | 370.0 | 563.0 | 862.5 | 1520.0 |
| United Kingdom | 80.0 | 85.0 | 350.0 | 409.0 | 712.5 | 900.0 |
| Sudan | 173.0 | 190.2 | 380.5 | 439.3 | 693.8 | 777.0 |
| Brazil | 60.0 | 388.5 | 555.0 | 596.3 | 832.5 | 1203.0 |
| BSS | 40.0 | 85.0 | 180.0 | 236.2 | 362.5 | 600.0 |
| SNMMI | 37.0 | 140.0 | 277.5 | 337.8 | 370.0 | 1110.0 |
| EANMMI | 40.00 | 79.75 | 141.00 | 193.88 | 242.50 | 500.00 |
| NCRP | 289.0 | 587.0 | 1185.0 | 916.2 | 1226.0 | 1294.0 |
| EU | 183.0 | 222.0 | 296.0 | 440.2 | 400.0 | 1100.0 |
Disclosures
Human subjects: Consent was obtained or waived by all participants in this study.
Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue.
Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following:
Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work.
Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work.
Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
Author Contributions
Concept and design: Ashutosh Pandey, Pankaj Sharma, Vandana K. Dhingra, Mayank Goswami, Prabhaker Mishra
Acquisition, analysis, or interpretation of data: Ashutosh Pandey
Drafting of the manuscript: Ashutosh Pandey
Critical review of the manuscript for important intellectual content: Ashutosh Pandey, Pankaj Sharma, Vandana K. Dhingra, Mayank Goswami, Prabhaker Mishra
Supervision: Pankaj Sharma, Vandana K. Dhingra, Mayank Goswami, Prabhaker Mishra
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