Using 18F-Fluorocholine PET to find parathyroid adenomas
18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
This study is testing if a special imaging technique using 18F-fluorocholine can help find overactive parathyroid glands in people with primary hyperparathyroidism before they have surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04895631 on ClinicalTrials.gov |
What this trial studies
This Phase III study evaluates the effectiveness of 18F-fluorocholine positron emission tomography (PET) in locating hyperfunctioning parathyroid glands in patients with primary hyperparathyroidism. Participants aged 13 and older with biochemically confirmed hyperparathyroidism will receive a single dose of 18F-fluorocholine during an imaging study. The results from the imaging will be compared to findings from subsequent parathyroid surgery to assess accuracy. This single-center study aims to improve detection methods for surgical candidates.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 13 and older with biochemically proven primary hyperparathyroidism who are indicated for surgery.
Not a fit: Patients who are currently pregnant or those deemed unsuitable for study participation by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of locating parathyroid adenomas, leading to better surgical outcomes for patients.
How similar studies have performed: Other studies using PET imaging for similar purposes have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 13 years. * Biochemically proven hyperparathyroidism and an indication for surgery. * Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * Current Pregnancy. * Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Hope, MD — University of California, San Francisco
- Study coordinator: Leena Awni
- Email: fch@ucsf.edu
- Phone: 415-514-8995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.