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NCT04895631 | RECRUITING | Hyperparathyroidism, Primary

18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
Sponsor:

Thomas Hope

Information provided by (Responsible Party):

Thomas Hope

Brief Summary:

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

Condition or disease

Hyperparathyroidism, Primary

Intervention/treatment

18F-Fluorocholine

Positron emission tomography (PET)

Phase

PHASE3

Detailed Description:

PRIMARY OBJECTIVE: 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 140 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
Actual Study Start Date : 2021-06-30
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 13 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

Location Details

NCT04895631

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How to Participate

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Locations

RECRUITING

United States, California

University of California, San Francisco

San Francisco, California, United States, 94107