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

Phase 3

Recruiting

• Conditions: Hyperparathyroidism, Primary
• Interventions: Drug: 18F-Fluorocholine; Procedure: Positron emission tomography (PET)

• Registration Number: NCT04895631
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorocholine PET Imaging	18F-Fluorocholine	Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Fluorocholine PET Imaging	Positron emission tomography (PET)	Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging	Up to 1 year	Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology as compared to sestamibi imaging. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold	Up to 1 year	Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology compared to a predefined threshold. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.

Secondary Outcome Measures

Name	Time	Method
Detection rate of 18F-fluorocholine PET	Up to 1 year	The detection rate of 18F-fluorocholine PET in participants who have not undergone surgical resection will be reported

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States