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NCT Number: NCT07444723

Accuracy of 18F-Fluorocholine PET/MR 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....

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Key information

Conditions

Primary Hyperparathyroidism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Head and Neck Neoplasms Heritable Hyperparathyroidism Hyperparathyroid-jaw Tumor Syndrome Hyperparathyroidism Hyperparathyroidism, Primary Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Multiple Endocrine Neoplasias Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Parathyroid Cancer Parathyroid Diseases Parathyroid Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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:

  • Evaluate positive predictive value 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 multi-gland disease (suspected or diagnosed with heritable forms of PHPT)

Secondary Objective:

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

  • Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT).
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

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.

Exclusion criteria

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.

Treatment and study plan

18F-FCH

Drug

Radiotracer for use in PET/MRI and PET/CT

NeuroEXPLORER

Device

PET/CT machine

Primary outcomes

  1. 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)

    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

  2. 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)

    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]

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)

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

    Will allow comparison of 18FFCH PET/MRI and PET/CT to conventional imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Lynn M Bliss

CONTACT

[email protected]

(301) 435-7921

Smita Jha, M.D.

CONTACT

[email protected]

(301) 827-1930

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2035
Study completion
2036
First posted
Mar 3, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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