NCT04895631

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Thomas Hope · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hyperparathyroidism, Primary

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-30
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2021-05-20
• Last updated: 2024-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study