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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positron-Emission Tomography
Positron-Emission Tomography
Secondary outcome measures
Detection rate of 18F-fluorocholine PET
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
9 Previous Clinical Trials
1,468 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
2,093 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 13 years old or older.I am 13 years old or older.I have been diagnosed with hyperparathyroidism and need surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Fluorocholine PET Imaging
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does 18F-Fluorocholine have the regulatory green light from the FDA?
"There is prior clinical evidence affirming 18F-Fluorocholine's safety, so it was given a 3."
Answered by AI
Are there any patients that you are still looking for to complete this clinical trial?
"Yes, according to the listing on clinicaltrials.gov, this study is still looking for patients. The trial was first posted on June 30th, 2021 and was last updated on October 31st, 2022. They are hoping to enroll 140 patients at a single site."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
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