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New imaging technique could help surgeons spot hidden parathyroid tumors

NCT ID NCT07444723

Diagnosis Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new type of PET scan using a radioactive tracer called 18F-FCH can more accurately locate overactive parathyroid glands or tumors before surgery. About 193 adults scheduled for parathyroid removal will receive both the new scans and a standard 4D-CT scan for comparison. The goal is to see if the new imaging reduces false positives and helps surgeons find the right gland the first time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-Fluorocholine (a radioactive tracer)
What this could lead to
If successful, this could make it easier and more accurate for surgeons to find parathyroid tumors before surgery, potentially improving outcomes and reducing repeat surgeries.
What could go wrong
This is an early-phase study focused on imaging accuracy, not treatment. The new scans may not prove significantly better than current methods, and the radioactive tracer carries a small radiation risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 193 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2036

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

familial primary hyperparathyroidism hereditary hyperparathyroidism hyperparathyroidism 2 with jaw tumors malignant tumor of parathyroid gland multiple endocrine neoplasia multiple endocrine neoplasia type 1 Parathyroid Neoplasms primary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heritable hyperparathyroidism Hyperparathyroid-jaw tumor syndrome Multiple endocrine neoplasias Parathyroid cancer Primary hyperparathyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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