Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 100Years
All Genders
NCT07444723

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

193

Participants Needed

1

Research Sites

511 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands. Objective: To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands. Eligibility: People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland. Design: Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples. Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine. Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan. Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights. Participants will have a follow-up visit 6 months after the surgery. This may be done remotely....

CONDITIONS

Official Title

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 100 years old
  • Willing to have parathyroidectomy at NIH Clinical Center
  • Diagnosed with sporadic primary hyperparathyroidism and a potential candidate for parathyroidectomy
  • Diagnosed with any form of heritable primary hyperparathyroidism (new or recurrent) and a potential candidate for parathyroidectomy
  • Clinically suspected of multi-gland disease or germline predisposition primary hyperparathyroidism syndrome
  • Suspected or diagnosed with parathyroid cancer and a potential candidate for parathyroidectomy
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical
  • For those able to become pregnant: unwilling to use highly effective contraception from two weeks before the first imaging scan until the date of parathyroidectomy
  • Use of any investigational product or device, except F-DOPA scans, within 30 days before the 18F-FCH scan
  • Unable or unwilling to provide informed consent
  • Any condition that would prevent safe completion of study participation as judged by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

L

Lynn M Bliss

CONTACT

S

Smita Jha, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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