Comparing two imaging methods for evaluating neuroblastoma in children
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
This study is testing which imaging method works better for spotting neuroblastoma in children by comparing two different techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05826158 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in children diagnosed with neuroblastoma. Participants must have a confirmed or presumed diagnosis of neuroblastoma and will undergo both imaging techniques within a specified timeframe. The results will be analyzed by independent teams of specialists to determine the accuracy of each imaging method in identifying neuroblastoma. The goal is to assess which imaging technique provides better diagnostic performance.
Who should consider this trial
Good fit: Ideal candidates are children with a confirmed or presumed diagnosis of neuroblastoma who are scheduled for imaging evaluations.
Not a fit: Patients who have received chemotherapy, immunotherapy, or radiotherapy between imaging studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of neuroblastoma diagnosis in children, leading to better treatment decisions.
How similar studies have performed: Other studies have shown promising results with similar imaging techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
Copenhagen
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Lise Borgwardt, MD, PhD. — Rigshospitalet, Denmark
- Study coordinator: Lise Borgwardt, MD, PhD.
- Email: lise.borgwardt@regionh.dk
- Phone: +4535459568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.