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

Thomas Hope

Status and phase

Enrolling

Phase 3

Conditions

Hyperparathyroidism, Primary

Treatments

Procedure: Positron emission tomography (PET)

Drug: 18F-Fluorocholine

Study type

Interventional

Funder types

Other

Identifiers

NCT04895631

20-32553

Details and patient eligibility

About

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

Full 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

Enrollment

140 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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.