Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma.

NCT07111117 | Not Yet Recruiting Phase 2

• 1 other identifier: IC 2021-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Neuroblastoma

Keywords

Neuroblastoma; PET / CT; Imaging; Radiotracer

Outcome Measures

Primary Outcomes (1)

• 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.

  The day of the PET/CT procedure

Secondary Outcomes (5)

• Description of discrepancies

  The day of the PET/CT procedure

• Dosimetric comparison between the two procedures

  The day of the PET/CT procedure

• Improvement of patient management during the diagnostic procedure

  The day of the PET/CT procedure

• Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)

  The day of the PET/CT procedure

• Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)

  The day of the PET/CT procedure

Study Arms (1)

18F-MFBG PET/CT imaging

EXPERIMENTAL

Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.

Procedure: 18F-MFBG PET/CT imaging

Interventions

18F-MFBG PET/CT imaging PROCEDURE

Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.

18F-MFBG PET/CT imaging

Eligibility Criteria

• Age: 365 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with histologically proven neuroblastoma.
• Relapsed or refractory neuroblastoma.
• I-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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Institut Curie

Paris, 75005, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tissot Hubert, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Cagnot

CONTACT

+33147111891; carole.cagnot@curie.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Neuroblastotep is a phase II, national, multicenter, prospective, interventional, open-label, non-randomized, single-arm pilot study (each patient being his own control). It is a concordance study comparing 18F-MFBG PET (= new diagnostic procedure) to 123I-MIBG scintigraphy (= gold standard) in neuroblastoma. 18F-MFBG is the radiopharmaceutical product.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: August 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (3)