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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorocholine PET Imaging | Experimental | Patients will undergo a single fluorocholine PET imaging study prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluorocholine | Drug | One-time injection of 4-7 millicurie (mCi) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94107 | United States |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C514960 | fluorocholine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron emission tomography (PET) | Procedure | Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities |
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