18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma

Study Overview
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Brief Summary
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This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma

Detailed Description
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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.

Official Title
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18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Diagnostic Test: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)


Participation Criteria
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Eligibility Criteria
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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: 1. Pregnancy -

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Children with Neuroblastoma<br> | Diagnostic Test: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)<br>* 18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT | Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 18F-mFBG with Clinical 123I-mIBG imaging | Pathological uptake on 18F-mFBG will be compared with pathological uptake on 123I-mIBG, lesions based comparison | 7 days apart | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-mFBG, meta-fluorobenzylguanidine, Large Axial Field of View PET/CT, LAFOV PET/CT, Total body PET/CT