Sharp 2009a.
| Clinical features and settings | Inclusion period: January 2003 to October 2007. Patient population: 60 patients with histologically proven neuroblastoma and a total of 113 paired ¹²³I‐MIBG and 18F‐FDG‐PET scans. Consecutive series: no; paired scans at one hospital were acquired for research purposes after informed consent was obtained; paired scans at the second hospital were obtained when requested by the oncology service for clinical reasons. Diagnostic work‐up: n.r. Time spans symptoms‐index test, symptoms‐reference standard and index test‐reference standard: n.r. Treatment between index test‐reference standard: n.r. |
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| Participants | Included patients: 24 children with a neuroblastoma and a ¹²³I‐MIBG scan at first diagnosis. Median age at diagnosis: n.r. for these 24 included patients; for all 60 patients: 3.1 years. Sex distribution: n.r. for these 24 included patients; for all 60 patients: 37 boys (62%), 23 girls (38%). INSS stage: 5 patients stage 1/2, 3 patients stage 3 and 16 patients stage 4. |
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| Study design | Case series with pathologically proven neuroblastoma (histopathology not known at the time of MIBG‐scintigraphy). | |
| Target condition and reference standard(s) | Target condition: newly diagnosed neuroblastoma. Reference standard: histopathology. If both ¹²³I‐MIBG and 18F‐FDG‐PET scans were negative:information concerning bone marrow biopsies and urinary catecholamines were provided. |
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| Index and comparator tests | Assessed primary objectives: 1.1 To determine the diagnostic accuracy of ¹²³I‐MIBG (SPECT‐CT) scintigraphy for detecting a neuroblastoma and its metastases at first diagnosis or at recurrence in children from 0 to 18 years old. 1.2 To determine the diagnostic accuracy of negative ¹²³I‐MIBG scintigraphy in combination with 18F‐FDG‐PET(‐CT) imaging for detecting a neuroblastoma and its metastases at first diagnosis or at recurrence in children from 0 to 18 years old. In this case 18F‐FDG‐PET(‐CT) is an add‐on test. Assessed secondary objectives: 2.1 To determine the diagnostic accuracy of 18F‐FDG‐PET(‐CT) imaging for detecting a neuroblastoma and its metastases at first diagnosis or at recurrence in children from 0 to 18 years old. 2.2 To compare the diagnostic accuracy of ¹²³I‐MIBG (SPECT‐CT) scintigraphy and of 18F‐FDG‐PET(‐CT) imaging for detecting a neuroblastoma and its metastases at first diagnosis or at recurrence in children from 0 to 18 years old. Positive test result for both ¹²³I‐MIBG and 18F‐FDG‐PET scans: uptake in primary and residual tumour, local and regional soft‐tissue (local/regional) metastases, and bone and bone marrow (bone/marrow) metastases. 1. ¹²³I‐MIBG scintigraphy: Three ¹²³I‐MIBG WB scans without SPECT and 110 ¹²³I‐MIBG WB scans with SPECT. The number of each dimension was n.r. for the 24 included patients only. Radiofarmacon: ¹²³I‐MIBG. Dose: 5.18 MBq/kg or 370 MBq/1.7 m² body surface area, depending on the institution, with a maximum dose of 370 MBq. Collimator: n.r. Matrix: 256 256. Acquisition protocol: WB scans and SPECT. SPECT: n.r. Acquisition time: n.r. Acquisition duration: n.r. Interfering medication: n.r. Thyroid prophylaxis: n.r. Number and expertise of investigators: n.r. Interobserver concordance: n.r. 18F‐FDG‐PET scintigraphy: 13 18F‐FDG‐PET only scans and 100 18F‐FDG‐PET scans with CT. The number of each dimension was n.r for the 24 included patients only. Radiofarmacon: 18F‐FDG‐PET. Dose: 5.18 or 5.55 MBq/kg, depending on the institution, with a maximum dosage of 444 MBq. Equipment: LS Discovery PET/CT scanner (GE Healthcare), Siemens Exact or Accel PET scanners, DSTe PET/CT scanner (GE Healthcare) or not reported. Acquisition protocol: n.r. Acquisition time: n.r. Acquisition duration: n.r. Number and expertise of investigators: n.r. Interobserver concordance: n.r. Blood glucose levels: n.r. |
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| Follow‐up | n.a. | |
| Notes | We received additional data from the author to fill in the two‐by‐two‐table of objective 1.1, 1.2, 2.1 and 2.2. | |
| Table of Methodological Quality | ||
| Item | Authors' judgement | Description |
| Representative spectrum? All tests | Unclear | Patients with proven stage 1 to 4 neuroblastoma were included, but age range n.r. |
| Acceptable reference standard? All tests | Yes | Histopathology. |
| Acceptable delay between tests? All tests | Unclear | n.r. |
| Partial verification avoided? All tests | Unclear | n.r. |
| Differential verification avoided? All tests | Unclear | Insufficient information regarding the different reference tests. |
| Incorporation avoided? All tests | Yes | Index test was not a part of the reference test. |
| Reference standard results blinded? All tests | Unclear | n.r. |
| Index test results blinded? All tests | Unclear | n.r. |
| Relevant clinical information? All tests | Unclear | n.r. |
| Uninterpretable results reported? All tests | Unclear | n.r. |
| Withdrawals explained? All tests | Yes | Results of all patients reported. |
| Selection criteria clearly described? All tests | Yes | Relevant information reported. |
| Sufficient detail for replication index test? All tests | No | SPECT, acquisition time and acquisition duration of ¹²³I‐MIBG scintigraphy n.r. Acquisition protocol, acquisition time and acquisition duration of 18F‐FDG‐PET scintigraphy n.r. |
| Sufficient detail for replication reference test? All tests | No | n.r. |
| Clear definition of positive result index test? All tests | Yes | Uptake in primary and residual tumour, local and regional soft‐tissue (local/regional) metastases, and bone and bone marrow (bone/marrow) metastases. |
| Interobserver variation reported and acceptable? All tests | Unclear | n.r. |
Abbreviations:
¹²³I‐MIBG: Iodine‐123‐metaiodobenzylguanidine; ¹³¹I‐MIBG: Iodine‐131‐metaiodobenzylguanidine; 18F‐FDG‐PET: fluorine‐18‐fluorodeoxy‐glucose positron emission tomography; 18F‐dopa PET: fluorine‐18‐dihydroxyphenylalanine positron emission tomography; 99mTc‐MDP: metastable‐technetium‐99‐methyldiphosphanate; cm: centimetre; COG: children's oncology group; CT: computed tomography; dopa PET: dihydroxyphenylalanine positron emission tomography; HVA: homovanillic acid; INSS: international neuroblastoma staging system; keV: kilo‐electron volt; kg: kilogram; m²: square metre; MBq: mega becquerel; MIBG: metaiodobenzylguanidine; min: minute; mm: millimetre; MRI: magnetic resonance imaging; n.a.: not applicable; n.r.: not reported; SD: standard deviation; SPECT: single photon emission computed tomography; US: ultrasound; VMA: vanillylmandelic acid; WB: whole‐body.