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

A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

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....

Study Overview

• Status: Recruiting
• Conditions: Primary Hyperparathyroidism; Parathyroid Cancer; Multiple Endocrine Neoplasias; Heritable Hyperparathyroidism; Hyperparathyroid-jaw Tumor Syndrome
• Intervention / Treatment: Drug: 18F-FCH; Device: NeuroEXPLORER

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 parathyroid cancer).

Objectives:

Primary Objectives:

1. Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
2. Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)

Secondary Objective:

1. Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism
2. Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)

Endpoints:

Primary Endpoints:

1. Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT).
2. Positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT).

Secondary Endpoint:

a. Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT

• Study Type: Interventional
• Enrollment (Estimated): 193
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Smita Jha, M.D.; Phone Number: (301) 827-1930; Email: smita.jha@nih.gov
• Study Contact Backup: Name: Lynn M Bliss; Phone Number: (301) 435-7921; Email: lynn.bliss@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: NIH Clinical Center Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov
      • Contact: Lynn Bliss; Phone Number: (301) 435-7921; Email: lynn.bliss@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-Arm; 18F-FCH injection for use in PET/CT and PET/MRI	Drug: 18F-FCH; Radiotracer for use in PET/MRI and PET/CT; Device: NeuroEXPLORER; PET/CT machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)	Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive when considering only positive diagnostic assessments. Positive Predictive Value would help in assessing frequency of false positives: Positive predictive value = true positive/ [true positives + false positives]	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)	Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive	Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism (PHPT)	Will allow comparison of 18FFCH PET/MRI and PET/CT to conventional imaging.	Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Smita Jha, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): February 5, 2035
• Study Completion (Estimated): February 5, 2036

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 29, 2026

More Information

Terms related to this study

• Keywords: MEN1; Primary hyperparathyroidism; Parathyroid Cancer; Heritable hyperparathyroidism; Hyperparathyroid-jaw tumor syndrome; Parathyroid adenomas
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases; Neoplastic Syndromes, Hereditary; Neoplasms, Multiple Primary; Multiple Endocrine Neoplasia; Hyperparathyroidism; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperparathyroidism, Primary; Parathyroid Neoplasms; Multiple Endocrine Neoplasia Type 1; fluorocholine
• Other Study ID Numbers: 10002081; 002081-DK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No