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. 2020 Aug 11;2(5):484–491. doi: 10.1093/jbi/wbaa057

Molecular Breast Imaging-guided Percutaneous Biopsy of Breast Lesions: A New Frontier on Breast Intervention

Beatriz E Adrada 1,✉, Tanya Moseley 1, S Cheenu Kappadath 2, Gary J Whitman 1, Gaiane M Rauch 1
PMCID: PMC7513587  PMID: 33015619

Abstract

Molecular breast imaging (MBI) is an increasingly recognized nuclear medicine imaging modality to detect breast lesions suspicious for malignancy. Recent advances have allowed the development of tissue sampling of MBI-detected lesions using a single-headed camera (breast-specific gamma imaging system) or a dual-headed camera system (MBI system). In this article, we will review current indications of MBI, differences of the two single- and dual-headed camera systems, the appropriate selection of biopsy equipment, billing considerations, and radiation safety. It will also include practical considerations and guidance on how to integrate MBI and MBI-guided biopsy in the current breast imaging workflow.

Keywords: molecular breast imaging, molecular breast imaging-guided biopsy, breast biopsy, image-guided biopsy

Key Messages.

  • Molecular breast imaging (MBI) is a functional imaging modality with similar diagnostic performance to breast MRI.

  • Molecular breast imaging-guided biopsy with single-headed and dual-headed cameras is a reliable and cost-effective means of percutaneous sampling of breast lesions.

  • The development of an MBI-guided biopsy device allows MBI to be fully integrated into the breast imaging workflow.

Introduction

Mammography is the only screening modality that has been proven to decrease breast cancer mortality, with a mortality reduction between 20% and 30% (1,2). However, the reported sensitivities of mammography are variable and range from 68%–88% (3,4). Consequently, several adjunct breast imaging modalities have emerged to overcome the limitations of screening mammography, particularly in patients with dense breasts, where the sensitivity of mammography can further decrease to 30% (5). Among them, functional imaging modalities, including breast MRI and molecular breast imaging (MBI), have become relevant to detect mammographically occult lesions. Although breast MRI is the most sensitive modality to detect cancer, with reported sensitivities of up to 98% (6), and has been shown to detect breast cancer at an earlier stage (7,8), the known shortcomings of breast MRI include variable specificity, ranging from 37%–97% (9–12), high cost, and limited tolerability. Additionally, MRI is a difficult imaging modality to implement into practice. Between 1% and 15% of patients referred for breast MRI are not able to tolerate the study because of claustrophobia (13–15). Other contraindications to breast MRI, such as implanted ferromagnetic devices, pacemakers, compromised renal function, and gadolinium allergy limit the performance of breast MRI. Molecular breast imaging is a promising functional imaging modality that provides a low-cost, claustrophobia-free alternative to MRI, with similar sensitivity and specificity for breast cancer screening, diagnosis, staging, and treatment response evaluation (16–19).

Molecular Breast Imaging

Molecular breast imaging is a dedicated nuclear medicine breast imaging technique that uses 99mTechnetium-sestamibi, a radiotracer with a high affinity to the mitochondria. The high cytoplasmic density of mitochondria is characteristic of tumor cells. Therefore, by using 99mTechnetium-sestamibi as a tracer, mitochondria on a cellular level are tagged, and the metabolic uptake is measured using gamma cameras optimized for imaging of the breast (20,21). The neoangiogenesis typical of cancerous tissue increases blood flow, which ultimately results in the increased delivery of 99mTechnetium-sestamibi to the tumor cells. Molecular breast imaging generates functional images of 99mTechnetium-sestamibi uptake in the breast tissue, unlike mammography, which generates anatomical images of the breast. Furthermore, in contrast to mammography, the sensitivity of MBI is not influenced by the density of the breast tissue, implants, architectural distortion, or scars from prior surgery or radiation. Also, MBI is a less expensive test than MRI, and patients with absolute and relative contraindications to breast MRI can safely undergo MBI (22).

MBI Cameras

Different types of breast-dedicated, small field-of-view gamma cameras are currently commercially available. The first commercially available system (circa 2000) was a single-headed scintillation detector (sodium iodide or cesium iodide) coupled to position-sensitive photomultiplier tubes and known as breast-specific gamma imaging (BSGI) (Dilon 6800, Dilon Technologies, Newport News, VA). The technology then evolved (circa 2010) into using a dual-headed, direct-conversion semiconductor cadmium zinc telluride (CZT) detector system (Discovery NM 750b, GE Healthcare, Milwaukee, WI and LumaGem 3200, CMR Naviscan, Northridge, CA), also known as MBI. Both systems provide high-resolution images of 99mTechnetium-sestamibi uptake in the breast in a mammographic configuration. Concerns about radiation have been an obstacle for MBI and BSGI systems to be integrated in clinical practice. Attempts have been made to reduce the adminstered dose of 99mTechnetium-setamibi from 20–30 mCi (740–1100 megabecquerels [MBq]) to 5–10 mCi (185–370 MBq), while keeping the same sensitivity and specificity of higher doses of 99mTechnetium-setamibi (23–25).

Indications for MBI, according to the Society of Nuclear Medicine and the American College of Radiology (26,27), include preoperative staging in patients with known breast cancer, evaluation of treatment response following neoadjuvant chemotherapy, detection of local breast recurrence, evaluation of an unknown primary in patients with axillary lymphadenopathy, evaluation of equivocal findings on mammography or ultrasound (US), and evaluation of patients with a contraindication to breast MRI. An MBI lexicon has been created to follow the Breast Imaging Reporting and Data System (BI-RADS) guidelines and to facilitate multimodality correlation (28). When MBI detects breast lesions classified as a BI-RADS category 4 or 5, correlation with mammography and targeted US examination is recommended. If a sonographic correlate for the MBI-detected lesion is confidently identified, biopsy should be performed under sonographic guidance. When there is no sonographic correlate, MBI-guided biopsy is now available to obtain accurate tissue sampling (Figure 1).

Figure 1.

Figure 1.

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Flowchart outlining workflow for suspicious molecular breast imaging (MBI)-detected lesions.

A recent meta-analysis (29) comparing the performance of MBI and breast MRI showed that MBI had a sensitivity to detect breast cancer comparable to MRI (82% vs 89%), with a higher specificity (82% vs 39%). Additional studies have shown MBI sensitivities ranging from 81%–91% (30–32). Molecular breast imaging as a supplemental imaging modality to mammography has shown an incremental cancer detection rate between 7.7 to 8.8 (33,34) and additional cancers per 1000 patients screened, with recall rates ranging from 5.9%–8.4%.

Although the performance of MBI has great potential to detect mammographically occult cancer, the lack of MBI-guided biopsy capability has delayed the full integration of MBI in the clinical workflow for breast imaging centers. Molecular breast imaging–detected lesions with no correlate on mammography or US had to undergo breast MRI and subsequent MRI-guided biopsy. In a study performed in 1585 patients (34) who underwent mammography and MBI as a supplemental imaging modality, 279 (17.6%) patients were recalled for diagnostic work-up, 175 (11.0%) had a positive mammographic finding, and 115 (7.2%) had a positive finding on MBI. Screening mammography alone recommended 21 biopsies in 20 patients (1.3%), and adjunct MBI recommended an additional 50 biopsies in 47 patients (3%). The majority of MBI-prompted biopsies were performed under US guidance (38 lesions, 2.4%), and 12 (0.8%) lesions were biopsied using MRI-guidance because of the lack of MBI-biopsy capability. In the last decade, biopsy capability has been developed for both single and dual detector systems, allowing MBI to become an integral part of a breast imaging department (Table 1).

Table 1.

MBI-guided Biopsy with Single-headed and Dual-headed Camera

Single-headed Camera Dual-headed Camera
99mTechnetium-sestamibi 600–800 MBq 600–800 MBq
Scout view Yes Yes
Angled stereo views Yes Yes
Coordinates x, y, and z Yes Yes
Verification rod 139Cerium 153Gadolinium
Specimen radiograph Yes Yes
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Single-headed Camera Biopsy (BSGI System)

The first nuclear medicine breast biopsy device approved by the United States Food and Drug Administration (FDA) in 2009 used the BSGI system (GammaLoc, Dilon Technologies Inc., Newport News, VA) with one detector. The principle of the BSGI-guided biopsy device is based on stereotactic localization of 99mTechnetium-sestamibi–avid lesions using a sliding slant-hole collimator to acquire two separate images at different angles. Two studies have been published using the single-head detector biopsy device. The first study was performed in 38 patients, and 50% of the lesions (19 lesions) were malignant. Of these 19 lesions, the median size was 12 mm (range 5–45 mm). The mean procedure time was 71 minutes (range, 44–112 minutes) (35).

The second study using the BSGI system was a retrospective review of 117 mammographically and sonographically occult lesions for which gamma-imaging biopsy was recommended in 112 women. Breast-specific gamma imaging biopsy was successfully performed on 104 lesions in 99 women, and it was canceled in 13 lesions. Thirty-two (30.8%) breast biopsies showed abnormal pathological findings, including malignancy and high-risk lesions. Of those 32 biopsies, 46.9% (15 lesions) of the lesions were malignant. The positive predictive value 3 (PPV3) for BSGI-guided biopsy was 16.3%, compared with 25% reported for breast MRI-guided biopsy (36,37).

Single-headed Camera Biopsy (BSGI System) Procedure

After the skin is cleansed appropriately and local anesthesia is administered, 600–800 MBq of 99mTechnetium-sestamibi is injected into an arm vein contralateral to the breast lesion. A scout view and 20-degree angle stereotactic views are obtained. The software (GammaLoc, Dilon Technologies Inc., Newport News, VA) calculates the x, y, and z coordinates. A skin nick is made, and the trocar needle is placed into the breast. Verification of the needle in the breast is acquired with a 99mTechnetium-sestamibi image, then the trocar needle is replaced by a 139Cerium source.

139Cerium has an emission energy of 165.8 keV and a half-life of 137 days. A second image is obtained under a dual-energy window that distinguishes the 139Cerium emission from 99mTechnetium-sestamibi to verify the correct position of the needle. The biopsy is performed using a 9-gauge vacuum-assisted device. A marker is placed after the biopsy. Specimen imaging with the single-headed camera is performed to confirm target retrieval.

Dual-headed Camera Biopsy (MBI System)

The first MBI-guided biopsy system (Discovery NM 750b, GE Healthcare, Milwaukee, WI) was approved by the FDA for standard clinical care in 2016. No publications are available to this date on the MBI-guided biopsy with a two-headed camera. This article details the initial experience using this device at our institution.

Five patients have undergone MBI-guided biopsy with the MBI-guided biopsy system (Discovery NM 750b) at our institution. All patients had breast lesions detected on MBI as BI-RADS category 4 (suspicious finding). Indications for MBI in these patients were breast cancer staging in four patients and for a palpable abnormality in one patient.

Dual-headed Camera (MBI System) Biopsy Device Description

The MBI-guided biopsy system is an optional accessory for the MBI camera. This biopsy unit has two detector arms equipped with two small CZT detectors. The CZT detectors are slanted towards one another at +30° and –30° angles. The angles allow for the acquisition of two stereotactic pairs of two-dimensional images, which determine the three-dimensional localization of the target lesion while the breast is held in place by the compression between the lower detector of the Discovery NM 750b and the compression paddle of the biopsy accessory. The biopsy needle is inserted into the breast through the gap between the two detectors.

Dual-headed Camera (MBI System) Biopsy Procedure

Case description: A 47-old patient with breast implants presented to our institution for evaluation of a palpable abnormality in the left breast. Mammography revealed a 4-cm focal asymmetry at the 2 o’clock position (Figure 2) correlating with the palpable abnormality. Ultrasound showed no correlate for the focal asymmetry. Therefore, MBI was performed and showed marked heterogeneous regional nonmass uptake in the upper outer quadrant (Figure 2). A second-look US was negative, and MBI-guided biopsy was recommended.

Figure 2.

Figure 2.

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47-year-old woman with a history of neurofibromatosis and a new palpable abnormality in the left breast. A: Mammography showed a focal asymmetry on the mediolateral oblique (MLO) view, corresponding to the palpable abnormality (triangle), which was sonographically occult. B: Molecular breast imaging (MBI) MLO view showed marked heterogeneous nonmass uptake in the upper outer quadrant of the left breast (solid arrow) correlating with the focal asymmetry seen on mammography and the palpable abnormality. The defect in the posterior region of the MBI corresponds to the patient’s implant (dashed arrow).

Dual-headed Camera (MBI System) Biopsy Technique

Molecular breast imaging images were reviewed to assess the feasibility of the MBI-guided biopsy and to select the optimal approach. In this case, a superior approach was selected because of the location of the lesion in the upper breast. The MBI-guided biopsy procedure was performed with the patient in the seated position. The patient was injected with 600–800 MBq of 99mTechnetium-sestamibi. Although the diagnostic MBI was performed with 300 MBq (8 mCi) of 99mTechnetium-sestamibi, 600–800 MBq was used to ensure optimal visibility of the target. Cranicaudal MBI images (Figure 3) were obtained to enable a superior to inferior approach and to ensure target visibility. Once the target was visualized, a scout scan was obtained of the targeted area to calculate the x and the y coordinates.

Figure 3.

Figure 3.

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Molecular breast imaging (MBI)-guided biopsy of the area of nonmass uptake in the left breast (see Figure 2) using a dual-headed camera. A: MBI imaging of the left breast was obtained in the selected approach (craniocaudal) to ensure target visibility. B: A scout view of the target lesion (red x) and stereotactic images were obtained to calculate the x and y coordinates. C:153Gadolinium source (arrow) was used to verify the needle position relative to the target. D: The verification image showed overlapping of the gadolinium rod (yellow circle) and the target (red x), indicating optimal positioning for the biopsy. E: Vacuum-assisted biopsy was performed with a 9-gauge needle. Twelve core-biopsy samples were obtained.

The biopsy unit was mounted to replace the superior detector. The skin was cleansed with aseptic technique, local anesthesia was performed, and an introducer was placed within the target lesion. The introducer used for this procedure is the same co-axial system used for MRI-guided biopsies. A verification rod (Figure 3), composed of 153Gadolinium that emits 103 keV with a half-life of 241 days, was placed in the introducer, and a verification scan was performed to ensure that the tip of the rod was at the center of the target. Once the correct position was confirmed, a 9-gauge vacuum-assisted biopsy needle was placed, and 12 samples were obtained. The D750 biopsy device supports several different biopsy systems (Mammotome, Leica Biosystems, Cincinnati, OH; EnCor, BARD Biopsy Systems, Tempe, AZ; and ATEC, Hologic, Marlborough, MA).

After the biopsy, a titanium marker was deployed in the biopsy bed. The specimen was placed in a plastic container (Figure 4) and scanned with the upper MBI detector. 99mTechnetium-sestamibi uptake was documented in the specimen, confirming target removal.

Figure 4.

Figure 4.

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Specimen imaging. The specimen in a plastic container (A) was placed on the top detector (B) to obtain a molecular breast imaging specimen image (C). This confirmed target retrieval as focal uptake (arrow) was noted in the specimen.

Postprocedural mammograms with two orthogonal views were performed to document marker placement and to assess the accuracy of clip placement at the MBI-guided biopsy site. The time to perform the procedure, defined as the time from the first MBI image to the specimen radiograph, was 90 minutes. The final pathology showed pseudoangiomatous stromal hyperplasia and columnar cell changes, which was considered concordant.

MBI Biopsy Challenges and Advantages

Molecular breast imaging has been proven to be an excellent imaging modality for the detection of breast cancer. Now with the addition of biopsy capability, MBI can be adopted as an alternative imaging modality to breast MRI. The PPV, cancer detection rates, and biopsy cancelation rates of single-camera MBI-guided biopsy and breast MRI are comparable (36,37). Although these results are promising, multiple-site clinical trials are needed to validate these results.

The concern about radiation dose and radiation risk from injected 99mTechnetium-sestamibi to perform MBI has been a barrier for MBI to be fully adopted in the breast imaging workflow. However, the effective dose of 240–300 MBq (6.5–8 mCi) of 99mTechnetium-sestamibi used for MBI corresponds to 2.4 millisievert (mSv), which is below the annual natural background radiation dose (38). The dose of 99mTechnetium-sestamibi used for an MBI-guided biopsy is higher (600–800 MBq) than the MBI dose used for screening or diagnostic purposes. The higher dose for biopsy is currently recommended to ensure optimal target visualization. We conducted a radiation survey during the first MBI-guided biopsy procedure to ensure the radiation safety of the personnel performing the procedure. The radiation exposure of the biopsy sample was at background levels (< 0.05 millirem per hour [mR/h]). Low levels of radiation confirmed that no special precautions are needed to transport or handle the MBI-guided biopsy specimen. The exposure rate for the personnel within 6 inches from the patient was measured to be 3 mR/hour. The total time for the operator in closest proximity to perform the biopsy, including localization and tissue extraction, was about 20 minutes. Thus, the estimated radiation exposure for the radiologist performing the biopsy was very low, measuring 1 mR (or an effective dose of 1 mSv).

The lengthy procedure time is an additional challenge for MBI-guided biopsy. The longer procedure time is explained by the prolonged acquisition times to demonstrate the lesion uptake of 99mTechnetium-sestamibi and the stereotactic and verification images after the biopsy needle are introduced. However, the procedure time and the amount of radiotracer used may be reduced with further experience and technological improvements such as postprocessing algorithms to improve conspicuity of the lesions detected on MBI (39).

Additional difficulties associated with MBI-guided biopsies are related to lesion location. Similar to the technical challenges of stereotactic biopsies, lesions close to the chest wall or the nipple may pose a challenge for percutaneous biopsy using MBI-guidance.

Potential advantages of MBI-guided biopsy are related to good patient tolerance of the procedure, lack of contraindications to MBI, no use of intravenous gadolinium, the ability to perform a specimen radiograph, and low cost relative to MRI-guided biopsy. The open MBI-guided biopsy design is especially advantageous for claustrophobic patients. Molecular breast imaging–guided biopsy can be performed in the sitting or in the decubitus position, facilitating lesion accessibility and improving patient comfort. Unlike MRI-guided breast biopsies, there are no contraindications for patients with implanted metallic devices or renal disease, and there are no weight limits. Additionally, MBI does not use intravenous gadolinium, which is reported to have a long-term deposition in the brain of uncertain clinical significance (40). The ability to perform specimen imaging to ensure adequate target retrieval is clearly an added advantage over MRI-guided breast biopsy.

Lastly, the higher cost of breast MRI and MRI-guided breast biopsies are known limitations (average $1000 and $3500, respectively) (41). Conversely, the national average cost of an MBI examination is $500, with MBI-biopsy costs approximating the cost of a stereotactic biopsy, which is about half of the cost of a MRI-guided biopsy. Given the significantly lower cost of MBI-guided biopsy compared to MRI-guided biopsy and patient tolerability, MBI-guided biopsy may be preferentially used in patients with MRI- and MBI-detected lesions rather than MRI-guided biopsy.

Conclusion

In summary, MBI-guided percutaneous biopsy is a safe, reliable, and cost-effective means of percutaneously sampling of breast lesions. Additional studies are needed to validate this relatively new technology.

Funding

Supported by the National Institutes of Health/National Cancer Institute (Cancer Center Support Grant P30 CA016672).

Conflicts of Interest Statement

B.E.A. and G.M.R. have received a research grant from GE Healthcare not related to the present article. S.C.K. has received a research grant from GE Healthcare not related to the present article.

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