18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- 18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT
Study Overview
Brief Summary
This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT
Time Frame: 60 minutes
Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT
Secondary Outcomes
- Comparison of 18F-mFBG with Clinical 123I-mIBG imaging(7 days apart)
Investigators
Lise Borgwardt
Senior Consultant Ph.D.
Rigshospitalet, Denmark