Performing [18F]MFBG Long-Axial-Field-of-View PET/CT Without Sedation or General Anesthesia for Imaging of Children with Neuroblastoma.
Lise Borgwardt, Jesper Brok, Kim Francis Andersen...
https://pubmed.ncbi.nlm.nih.gov/38960713Actively Recruiting
Phase Not Applicable
Age: 0 - 18Years
All Genders
ID05826158
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
Led by Rigshospitalet, Denmark · Updated on 2024-11-15
25
Participants Needed
1
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of the radiopharmaceutical 18F-mFBG in PET/CT imaging compared to the established 123I-mIBG scintigraphy SPECT/CT scans for children with neuroblastoma. The study aims to assess how well 18F-mFBG can identify neuroblastoma lesions and compare its diagnostic performance with that of 123I-mIBG imaging. Participants include children with either a confirmed or presumed diagnosis of neuroblastoma based on clinical, imaging, and laboratory findings. Participants will undergo both 18F-mFBG PET/CT and 123I-mIBG scintigraphy scans within a 7-day window, without receiving chemotherapy, immunotherapy, or radiotherapy between these imaging procedures. The 18F-mFBG imaging is performed using a large field of view total body PET/CT scanner. Two independent teams, each consisting of a nuclear medicine physician and a pediatric radiologist, will review both imaging types while blinded to results. Discrepancies in lesion detection between the two scans will be reviewed by an expert panel. During the study, participants will have two diagnostic imaging sessions spaced closely in time. The study will evaluate lesion detection and imaging consistency through expert blinded readings. The primary outcome focuses on the ability of 18F-mFBG PET to identify neuroblastoma lesions within 60 minutes. Secondary outcomes compare the 18F-mFBG results with the clinical 123I-mIBG scans performed within seven days. The study involves informed consent and careful monitoring but does not involve treatment interventions.
CONDITIONS
Brief Title
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children with a confirmed diagnosis of neuroblastoma based on tissue biopsy at any time before enrollment
- Children with a presumed diagnosis of neuroblastoma based on signs, symptoms, physical exam, imaging, laboratory, and genetic test results
- Participants who have had or are scheduled to have a 123I-mIBG scan within 7 days before or after the 18F-mFBG scan
- No chemotherapy, immunotherapy, or radiotherapy between the 123I-mIBG and 18F-mFBG imaging
- Ability of the participant or legal guardian to understand and sign informed consent
You will not qualify if you...
- Pregnancy
AI-Screening
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1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 weeks
Participants undergo two imaging procedures to evaluate neuroblastoma: a 123I-mIBG scan and an 18F-mFBG PET/CT scan performed within 7 days of each other without any chemotherapy, immunotherapy, or radiotherapy between the scans.
2 imaging visits (in-person) within 7 days
Trial Site Locations
Total: 1 location
1
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Actively Recruiting
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Research Team
L
Lise Borgwardt, MD, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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