Recruiting
Phase 2
Phase 3

PET/MRI & NeuroEXPLORER PET-CT

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT07444723

Conditions

Primary Hyperparathyroidism

Parathyroid Cancer

Multiple Endocrine Neoplasias

Heritable Hyperparathyroidism

Hyperparathyroid-jaw Tumor Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-FCH

NeuroEXPLORER

Study Details

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 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

Primary Hyperparathyroidism

Parathyroid Cancer

Multiple Endocrine Neoplasias

Heritable Hyperparathyroidism

Hyperparathyroid-jaw Tumor Syndrome

Study ID

NCT07444723

Start date

Apr 16, 2026

Status verified date

May 29, 2026

Completion date

Feb 5, 2036

Anticipated

Primary completion date

Feb 5, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

193 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single-Arm

18F-FCH injection for use in PET/CT and PET/MRI

Interventions

18F-FCH

Radiotracer for use in PET/MRI and PET/CT

NeuroEXPLORER

PET/CT machine

Primary outcome measure

  • Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) [ Time Frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) ]
  • Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) [ Time Frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) ]

Central Contacts and Locations

Central contacts

Lynn M Bliss

(301) 435-7921lynn.bliss@nih.gov

Smita Jha, M.D.

(301) 827-1930smita.jha@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

Lynn Bliss

(301) 435-7921lynn.bliss@nih.gov

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Jun 2, 2026

Last verified

May 29, 2026

Keywords

  • Primary hyperparathyroidism
  • Parathyroid Cancer
  • MEN1
  • Heritable hyperparathyroidism
  • Hyperparathyroid-jaw tumor syndrome
  • Parathyroid adenomas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.