Clinical trial · Interventional
Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma.
Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma
NCT07111117CI-TRIAL-00094448NEUROBLASTOTEPnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-MFBG PET/CT imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-MFBG PET/CT imaging
- description
- Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.
- interventionNames
- Procedure: 18F-MFBG PET/CT imaging
Primary outcomes (1)
- measure
- Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
- timeFrame
- The day of the PET/CT procedure
- description
- % patients in whom concordance between the 2 procedures is reached.
Secondary outcomes (5)
- measure
- Description of discrepancies
- timeFrame
- The day of the PET/CT procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 365 Days
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven neuroblastoma. 2. Relapsed or refractory neuroblastoma. 3. 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. 4. No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET/CT (PET/CT shall not delay therapeutic management.) 5. Age ≥ 365 days to \< 18 years old. For children under 13 months, day of birth should be collected. 6. Weight ≥ 9 kg. 7. Performance Status: Lansky or Karnofsky ≥ 60%. 8. Signed written informed consent by the 2 holders of the parental authority or legal representative(s). 9. Patients covered by a health insurance system. Exclusion Criteria: 1. Patient inability to comply with protocol requirements without general anesthesia. 2. 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. 3. Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG. 4. 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
References
Publications (0)
Data not yet available
No reference posted for this study.