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

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.

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

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.