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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperparathyroidism, Primary
• Intervention / Treatment: Drug: 18F-Fluorocholine; Procedure: Positron emission tomography (PET)

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
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daniel Thompson; Phone Number: 415-514-8995; Email: fch@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Recruiting
      • University of California, San Francisco
      • Contact: Daniel Thompson; Email: Daniel.Thompson@ucsf.edu
      • Contact: UCSF Fluorocholine Team; Phone Number: 415-514-8995; Email: fch@ucsf.edu
      • Principal Investigator: Thomas Hope, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorocholine PET Imaging; Patients will undergo a single fluorocholine PET imaging study prior to surgery.	Drug: 18F-Fluorocholine; One-time injection of 4-7 millicurie (mCi); Other Names: Fluorocholine; Procedure: 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 Names: PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Hope
• Investigators: Principal Investigator: Thomas Hope, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma; Parathyroid Neoplasms
• Other Study ID Numbers: 20-32553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No