The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography / Computed Tomography scan (PET/CT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma.
Patients with histologically proven neuroblastoma.
Relapsed or refractory neuroblastoma.
123I-MIBG avid neuroblastoma (positive 123I-MIBG scintigraphy = showing at least one neuroblastoma lesion (either primary or metastatic) with a significant avidity for 123I-MIBG), performed within 2 weeks to 2 days prior to 18F-MFBG PET/CT.
No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET/CT (PET/CT shall not delay therapeutic management.)
Patient inability to comply with protocol requirements without general anesthesia.
Pregnant or breastfeeding patient. If indicated, at the investigator's discretion, patients of childbearing potential should have urinary pregnancy test the day of the PET/CT procedure, prior to the MFBG administration.
Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG.
Patient with a parent or legal representative with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid informed consent
Single group
18F-MFBG PET/CT imaging
Procedure/SurgeryParticipants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.
Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
% patients in whom concordance between the 2 procedures is reached.
Description of discrepancies
In case of non-perfect agreement, the observed discrepancies will be described. Agreement between the SIOPEN and Curie scores will be estimated.
Dosimetric comparison between the two procedures
One-point activity concentration measurement for normal organs (lung, liver, renal parenchyma, pancreas, spleen, adrenal gland, bladder, thyroid, heart, gonadic, eyes).
Improvement of patient management during the diagnostic procedure
Improvement of patient management will be evaluated by a short satisfaction survey after PET procedure, using satisfaction scales. The satisfaction and feeling variables will be described for the 123I-MIBG scintigraphy and 18F-MFBG PET/CT examinations by their repartition for the qualitative variables and by their distribution
Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)
PET images will be acquired in list-mode to ensure multiple reconstruction for different acquisition duration, in order to determine optimal duration.
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