Investigating a new imaging technique for neuroblastoma

Phase 1

• Conditions: euroblastoma; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003713-33-NL
• Lead Sponsor: Princess Máxima Center for pediatric oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with a (clinical suspicion of) neuroblastoma who are referred for [123I]mIBG imaging;
Age 0 – 18 years;
Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy of patient
Age > 18 years old

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare [18F]mFBG PET-CT imaging for neuroblastoma patients with the current standard of imaging, [123I]mIBG SPECT, using the SIOPEN score for skeletal lesions and the number of detected soft tissue lesions as endpoints. ;Secondary Objective: To determine the optimal time point for [18F]mFBG PET-CT acquisition;<br>To calculate, in a subset of patients, the radiation absorbed dose of [18F]mFBG for patients using dynamic PET imaging;<br>To determine the short-term safety and tolerability of [18F]mFBG .<br>;Primary end point(s): 1.Number of neuroblastoma lesions detected with [18F]mFBG PET-CT compared to [123I]mIBG imaging, segment based using SIOPEN scoring method; <br>2.Absolute number of soft tissue lesions detected with [18F]mFBG PET-CT compared to [123I]mIBG imaging.<br>;Timepoint(s) of evaluation of this end point: Post acquisition of [18F]mFBG PET-CT and [123I]mIBG imaging

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Optimal imaging time point of [18F]mFBG PET acquisition (60 minutes vs 120-150 minutes post injection<br>2. Radiation absorbed dose of [18F]mFBG from patients that underwent a dynamic PET-CT scan<br>3. Adverse events encountered after 18F-mFBG injection.<br>;Timepoint(s) of evaluation of this end point: 1.Post acquisition of [18F]mFBG PET-CT;<br>2. Post acquisition of [18F]mFBG PET-CT;<br>3. Up to 72 hours post injection.