18F‑Fluorocholine PET/MRI and NeuroEXPLORER PET/CT to locate parathyroid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who are planning parathyroidectomy for primary or heritable hyperparathyroidism or suspected parathyroid cancer will receive 18F‑Fluorocholine PET/MRI and NeuroEXPLORER PET/CT scans in addition to the standard 4D‑CT imaging. The study compares the positive predictive value of the new PET techniques to 4D‑CT for locating abnormal parathyroid tissue. Participants will have screening visits, blood tests, and up to four clinic or hospital visits for imaging and surgical care at the NIH Clinical Center. Surgical findings will be used as the reference standard to determine how accurately each imaging method identified the abnormal glands.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Smita Jha, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Lynn M Bliss
• Email: lynn.bliss@nih.gov
• Phone: (301) 435-7921

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.