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18F-Fluorocholine PET for Parathyroid Adenomas

Phase 3
Recruiting
Led By Thomas Hope, MD
Research Sponsored by Thomas Hope
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 13 years.
Age >= 13 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test if 18F-fluorocholine can help find parathyroid adenomas.

Who is the study for?
This trial is for individuals aged 13 or older with biochemically proven hyperparathyroidism who need surgery. Participants must be able to understand and sign a consent form. Pregnant individuals or those unlikely to follow study procedures are not eligible.
What is being tested?
The study is testing the effectiveness of a substance called 18F-Fluorocholine used in PET scans to locate parathyroid adenomas in patients with primary hyperparathyroidism.
What are the potential side effects?
While the document doesn't list specific side effects, generally, PET scan substances can cause reactions like mild pain, redness at the injection site, or rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 13 years old or older.
Select...
I am 13 years old or older.
Select...
I have been diagnosed with hyperparathyroidism and need surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Positron-Emission Tomography
Positron-Emission Tomography
Secondary study objectives
Detection rate of 18F-fluorocholine PET

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: Fluorocholine PET ImagingExperimental Treatment2 Interventions
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-Fluorocholine
2016
Completed Phase 3
~100
Positron emission tomography (PET)
2008
Completed Phase 3
~70

Find a Location

Who is running the clinical trial?

Thomas HopeLead Sponsor
10 Previous Clinical Trials
1,682 Total Patients Enrolled
Thomas Hope, MDPrincipal Investigator - University of California, San Francisco
Medical School - Boston University
Georgetown University Hospital, Residency in Anesthesiology
11 Previous Clinical Trials
2,108 Total Patients Enrolled

Media Library

18F-Fluorocholine Clinical Trial Eligibility Overview. Trial Name: NCT04895631 — Phase 3
Primary Hyperparathyroidism Research Study Groups: Fluorocholine PET Imaging
Primary Hyperparathyroidism Clinical Trial 2023: 18F-Fluorocholine Highlights & Side Effects. Trial Name: NCT04895631 — Phase 3
18F-Fluorocholine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895631 — Phase 3
~44 spots leftby Jun 2026
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