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

NCT07444723 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10002081002081-DK
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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

Heritable Hyperparathyroidism; Parathyroid Cancer; Primary Hyperparathyroidism; Multiple Endocrine Neoplasias; Hyperparathyroid-jaw Tumor Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (1)

• Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism (PHPT)

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

Study Arms (1)

Single-Arm

EXPERIMENTAL

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

Drug: 18F-FCH; Device: NeuroEXPLORER

Interventions

18F-FCH DRUG

Radiotracer for use in PET/MRI and PET/CT

Single-Arm

NeuroEXPLORER DEVICE

PET/CT machine

Single-Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, an individual must meet all the following criteria:
• Aged 18-100 years old
• Willing to have parathyroidectomy at NIH Clinical Center
• Meets one of the following:
• Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
• 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
• Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnancy or lactation
• Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
• 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
• Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
• Unable or unwilling to provide informed consent.
• Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Parathyroid Neoplasms; Multiple Endocrine Neoplasia Type 1

Interventions

fluorocholine

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Multiple Endocrine Neoplasia; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Smita Jha, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn M Bliss

CONTACT

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

Smita Jha, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 3, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): February 5, 2035
• Study Completion (Estimated): February 5, 2036
• Last Updated: June 2, 2026

Record last verified: 2026-05-29

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)