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Cancer Imaging Agent
18F Fluorocholine PET/CT for Parathyroid Tumors (18FCH Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Andrei Iagaru
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour
Awards & highlights
No Placebo-Only Group
Summary
"This trial will use a common PET isotope called Fluorine-18 bound to Choline to study participants with suspected parathyroid adenoma and unclear test results from a standard imaging test."
Who is the study for?
This trial is for people with suspected parathyroid adenoma, which means they have high calcium levels and normal or high parathyroid hormone levels but unclear results from a standard SPECT/CT scan. Participants must be able to consent, have certain liver function test results within acceptable limits, and not be pregnant.
What is being tested?
The study is testing the effectiveness of using Fluorine-18 (18F) bound to Choline in PET/CT scans for identifying parathyroid adenomas when standard imaging with 99mTc Sestamibi SPECT/CT isn't clear. It's a single-center study where all participants will receive the new imaging technique.
What are the potential side effects?
While specific side effects are not detailed here, PET/CT scans generally may cause discomfort due to injection of the tracer substance and require patients to lie still during imaging. There's also exposure to radiation similar to other medical imaging procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 18FCH PET/CTExperimental Treatment1 Intervention
Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area.
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Who is running the clinical trial?
Andrei IagaruLead Sponsor
15 Previous Clinical Trials
496 Total Patients Enrolled
Andrei Iagaru, MDStudy DirectorStanford University
6 Previous Clinical Trials
442 Total Patients Enrolled