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

NCT07444723 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DRUG

18F-FCH

Radiotracer for use in PET/MRI and PET/CT

DEVICE

NeuroEXPLORER

PET/CT machine

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Smita Jha, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2035-02-05
Completion
2036-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444723 on ClinicalTrials.gov