Clinical trial · Interventional
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
NCT05826158CI-TRIAL-00082583recruitingN/AClinicalTrials.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)
This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of 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 |
|---|---|---|---|
| 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Children with Neuroblastoma
- interventionNames
- Diagnostic Test: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
Primary outcomes (1)
- measure
- 18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT
- timeFrame
- 60 minutes
- description
- Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT
Secondary outcomes (1)
- measure
- Comparison of 18F-mFBG with Clinical 123I-mIBG imaging
- timeFrame
- 7 days apart
- description
- Pathological uptake on 18F-mFBG will be compared with pathological uptake on 123I-mIBG, lesions based comparison
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. An established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrolment in the trial; OR b) A presumed diagnosis of neuroblastoma based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results, including individuals in whom therapy has already been empirically initiated. 2. The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including 123I-mIBG +/- 7 days to the date of 18F-mFBG imaging, with no therapy between such evaluation. 3. Ability of subject or subject's legal guardian to understand and sign a written informed consent document. \- Exclusion Criteria: 1\. Pregnancy \-
References
Publications (1)
- DERIVEDBorgwardt L, Brok J, Andersen KF, Madsen J, Gillings N, Fosbol MO, Denholt CL, Petersen IN, Sorensen LS, Enevoldsen LH, Oturai PS, Johannesen HH, Hojgaard L, Schulze C, Saxtoft E, Andersen F, Fischer BM. Performing [18F]MFBG Long-Axial-Field-of-View PET/CT Without Sedation or General Anesthesia for Imaging of Children with Neuroblastoma. J Nucl Med. 2024 Aug 1;65(8):1286-1292. doi: 10.2967/jnumed.123.267256. PMID 38960713