18F-Fluorocholine for the Detection of Parathyroid Adenomas

Study Overview
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Brief Summary
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The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Official Title
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18F-Fluorocholine 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: Biochemically proven hyperparathyroidism and an indication for surgery Age >= 13 years old Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent). Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.). Pregnancy.

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: 18F-Fluorocholine PET<br>Patients will undergo a single fluorocholine PET imaging study prior to surgery. | Drug: 18F-Fluorocholine<br>* Given intravenously<br>* Other names: Fluorocholine;Procedure: Positron Emission Tomography (PET)<br>* Imaging technique that uses radioactive agents 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 True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma | The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year. | Up to 1 year | 
| Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging | The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Rate in Patients Who Have Not Undergone Surgical Resection | The detection rate is defined as the proportion of participants with a 18F-fluorocholine PET positive read who do not subsequently undergo parathyroidectomy, using the dictated reports to determine the detection sensitivity for parathyroid adenomas. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron emission tomography