Hyperparathyroidism, Primary
Conditions
Brief summary
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
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
Interventions
One-time injection of 4-7 millicurie (mCi)
PROCEDUREPositron emission tomography (PET)
Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Sponsors
Thomas Hope
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging | Up to 1 year | 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. |
| Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold | Up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of 18F-fluorocholine PET | Up to 1 year | The detection rate of 18F-fluorocholine PET in participants who have not undergone surgical resection will be reported |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Hope, MD
University of California, San Francisco
Outcome results
None listed