18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
NCT ID: NCT04895631
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2021-06-30
2027-06-30
Brief Summary
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Detailed Description
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I. To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.
OUTLINE:
Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Fluorocholine PET Imaging
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
18F-Fluorocholine
One-time injection of 4-7 millicurie (mCi)
Positron emission tomography (PET)
Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Interventions
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18F-Fluorocholine
One-time injection of 4-7 millicurie (mCi)
Positron emission tomography (PET)
Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biochemically proven hyperparathyroidism and an indication for surgery.
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
* Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
13 Years
ALL
No
Sponsors
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Thomas Hope
OTHER
Responsible Party
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Thomas Hope
Associate Professor
Principal Investigators
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Thomas Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Leena Awni
Role: primary
UCSF Fluorocholine Team
Role: backup
Other Identifiers
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20-32553
Identifier Type: -
Identifier Source: org_study_id