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

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

Recruiting
13 years and older
All
Phase 3

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Overview

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

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.

Study details
    Hyperparathyroidism
    Primary

NCT04895631

Thomas Hope

27 January 2024

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