Status:
RECRUITING
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Primary Hyperparathyroidism
Parathyroid Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
Brief Summary
Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different pla...
Detailed Description
Study Description: This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary hyperparathyroidism (sporadic or heritable forms and parathyro...
Eligibility Criteria
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all the following criteria:
-
Aged 18-100 years old
-
Willing to have parathyroidectomy at NIH Clinical Center
-
Meets one of the following:
- Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
- Diagnosed with any forms of heritable primary hyperparathyroidism (index presentation or recurrent disease) and is a potential candidate for parathyroidectomy. Participants clinically suspected of multi-gland disease (individuals with secondary/tertiary hyperparathyroidism) or germline predisposition PHPT syndrome are included in this cohort
- Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
- Unable or unwilling to provide informed consent.
- Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
Key Trial Info
Start Date :
April 22 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2036
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT07444723
Start Date
April 22 2026
End Date
February 5 2036
Last Update
April 17 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892