Clinical trial · Observational
A Prospective Image Reevaluation Study to Assess the Efficacy of 18F-mFBG PET Imaging in Subjects With Neuroblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a prospective image revaluation study designed to assess the performance of 18F-mFBG PET imaging in detecting the presence of neuroblastoma. Eligible participants will have undergone 18F-mFBG PET imaging in a research trial or locally-authorized clinical use and have: a) an established diagnosis of active neuroblastoma; or b) an established diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma based on signs, symptoms, imaging findings, and laboratory results.
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 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 18F-mFBG Revaluation Group
- description
- Subjects previously administered 18F-mFBG with: a) a current diagnosis of neuroblastoma; b) a diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma.
- interventionNames
- Drug: 18F-MFBG
Primary outcomes (1)
- measure
- Determine Sensitivity, Specificity, Positive and Negative Predictive Percent Agreement (PPA/NPA) of 18F-mFBG
- timeFrame
- Blinded Reader review over 2-3 weeks.
- description
- The primary objective of this study is to demonstrate that 18F-mFBG PET scintigraphy (PET/CT or PET/MR) is sensitive and specific (in terms of positive and negative percent agreement (PPA and NPA) on a subject-level in confirming or excluding the presence of neuroblastoma.
Secondary outcomes (1)
- measure
- PPA/NPA on a region/organ system level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * a) The subject has undergone 18F-mFBG imaging in a previous research trial (including as a non-disease control) or locally-authorized clinical use. Disease status (+ or - for neuroblastoma) as of the date of 18F-mFBG imaging was established based on data collected as part of the previous clinical trial or locally-authorized clinical use or during subsequent clinical follow-up. Exclusion Criteria: \- 1. There is insufficient correlative imaging and clinical follow-up data to establish subject disease status as of the date of 18F-mFBG imaging. 2\. 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.
References
Publications (0)
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