To hear about similar clinical trials, please enter your email below
Trial Title:
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
NCT ID:
NCT05826158
Condition:
Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Conditions: Keywords:
18F-mFBG
meta-fluorobenzylguanidine
Large Axial Field of View PET/CT, LAFOV PET/CT
Total body PET/CT
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
Description:
18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
Arm group label:
Children with Neuroblastoma
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.
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.
Criteria for eligibility:
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
-
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet, Copenhagen University Hospital
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Lise Borgwardt, MD Ph.D.
Phone:
+4535459568
Email:
lise.borgwardt@regionh.dk
Start date:
June 6, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05826158
