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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hyperparathyroidism, Primary

Intervention / Treatment
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* Drug: 18F-Fluorocholine
* Procedure: Positron emission tomography (PET)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorocholine PET Imaging<br>Patients will undergo a single fluorocholine PET imaging study prior to surgery. | Drug: 18F-Fluorocholine<br>* One-time injection of 4-7 millicurie (mCi)<br>* Other names: Fluorocholine;Procedure: Positron emission tomography (PET)<br>* Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities<br>* Other names: PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |