18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
Study Details
Study Description
Brief Summary
This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a prospective study designed to assess the use of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results.
Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG within +/- 7 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies.
18F-mFBG PET studies will be evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.
The clinical 123I-mIBG is also evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.
Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with neuroblastoma.
Subject-level diagnostic performance will be assessed on the basis of differencies in lesion-counting between the blinded 18F-mFBG scan interpretation and the 123I-mIBG scan. In case of discrepancy, independently assessed by an Expert Panel.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Children with Neuroblastoma
|
Diagnostic Test: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
|
Outcome Measures
Primary Outcome Measures
- 18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT [60 minutes]
Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT
Secondary Outcome Measures
- Comparison of 18F-mFBG with Clinical 123I-mIBG imaging [7 days apart]
Pathological uptake on 18F-mFBG will be compared with pathological uptake on 123I-mIBG, lesions based comparison
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
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.
-
Ability of subject or subject's legal guardian to understand and sign a written informed consent document.
Exclusion Criteria:
- Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet, Copenhagen University Hospital | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Principal Investigator: Lise Borgwardt, MD, PhD., Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- j. nr. H-21009982_v3