18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise Borgwardt, MD, PhD.
- Phone Number: +4535459568
- Email: lise.borgwardt@regionh.dk
Study Locations
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-
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Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet, Copenhagen University Hospital
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Contact:
- Lise Borgwardt, MD Ph.D.
- Phone Number: +4535459568
- Email: lise.borgwardt@regionh.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
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Exclusion Criteria:
1. Pregnancy
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Children with Neuroblastoma
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18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of 18F-mFBG with Clinical 123I-mIBG imaging
Time Frame: 7 days apart
|
Pathological uptake on 18F-mFBG will be compared with pathological uptake on 123I-mIBG, lesions based comparison
|
7 days apart
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lise Borgwardt, MD, PhD., Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- j. nr. H-21009982_v3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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