NCT07111117Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Jan 2024
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Institut Curie
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT07111117
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Mar 2026 to the primary completion date, 30 Sept 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Patient inability to comply with protocol requirements without general anesthesia.
- Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG.
Who the study is looking for
- 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.)
- Age ≥ 365 days to \< 18 years old. For children under 13 months, day of birth should be collected.
- Weight ≥ 9 kg.
- Performance Status: Lansky or Karnofsky ≥ 60%.
- Signed written informed consent by the 2 holders of the parental authority or legal representative(s).
- Patients covered by a health insurance system.
Age in the registry: 365 days to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.