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

Hyperparathyroidism, Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895631
• Other study ID #: 20-32553
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Daniel Thompson
• Phone: 415-514-8995
• Email: fch[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Neoplasms

Intervention

Drug:
• 18F-Fluorocholine
One-time injection of 4-7 millicurie (mCi)

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Hope

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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