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

NCT04895631 | Completed Phase 3 FDA Drug

• 1 other identifier: 20-32553
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism, Primary

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging

  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.

  Up to 1 year

• Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold

  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.

  Up to 1 year

Secondary Outcomes (1)

• Detection rate of 18F-fluorocholine PET

  Up to 1 year

Study Arms (1)

Fluorocholine PET Imaging

EXPERIMENTAL

Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Drug: 18F-Fluorocholine; Procedure: Positron emission tomography (PET)

Interventions

18F-Fluorocholine DRUG

One-time injection of 4-7 millicurie (mCi)

Also known as: Fluorocholine

Fluorocholine PET Imaging

Positron emission tomography (PET) PROCEDURE

Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities

Also known as: PET

Fluorocholine PET Imaging

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current Pregnancy.
• Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Sponsors & Collaborators

• Thomas Hope: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

fluorocholine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 20, 2021
• Study Start: June 30, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)