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:

  1. Aged 18-100 years old

  2. Willing to have parathyroidectomy at NIH Clinical Center

  3. Meets one of the following:

    1. Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
    2. 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
    3. 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:

  1. Pregnancy or lactation
  2. Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
  3. 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
  4. Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
  5. Unable or unwilling to provide informed consent.
  6. 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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Page 1 of 1 (1 locations)

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892