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New PET tracer aims to reveal hidden Hormone-Making tumors

NCT ID NCT06246357

Diagnosis Sponsor: National Cancer Institute (NCI) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 30, 2026 · Updated 4 times

Summary

This phase 2 study tests a radioactive tracer called [68Ga]Ga-PentixaFor to see if it can better identify adrenal tumors that produce excess hormones like aldosterone or cortisol. About 80 adults with known adrenal tumors and high hormone levels will receive the tracer before a PET scan. The goal is to improve diagnosis of functional adrenal tumors, which could guide treatment decisions.

What this could mean

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

Active substance
[68Ga]Ga-PentixaFor (a radioactive tracer)
What this could lead to
If successful, this tracer could make it easier to identify which adrenal tumors are producing excess hormones, helping doctors choose the right treatment.
What could go wrong
This is an early phase 2 study with only 80 participants, so results may not apply to everyone. The tracer is still experimental and its accuracy needs further validation.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

Sep 2024

Expected to finish

Apr 2028

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 120 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: * Must have any of the following: * one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone OR --ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI OR * history of ACTH-dependent hypercortisolism (with or without adrenal enlargement) * Co-enrollment in 19-DK-0066, 09-C-0242, 18-CH-0031 or a similar NIH trial. * Age \>=18 years. * ECOG performance status \<= 2. * Women of child-bearing potential (WOCBP) and men must agree to use an effective contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) for two weeks prior to \[68Ga\]Ga-PentixaFor scan and for one week after the \[68Ga\]Ga-PentixaFor scan. * Breastfeeding should be discontinued for one week after the \[68Ga\]Ga-PentixaFor scan. * Men must agree not to donate sperm for one week after the \[68Ga\]Ga-PentixaFor scan. * Participants must be able to understand and willing to sign a written informed consent document. EXCLUSION CRITERIA: * Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening. * Uncontrolled intercurrent illness or social situations based on the review of medical history that would limit compliance with study requirements. * Contraindications to having an MRI and CT.

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Conditions

The condition(s) this trial relates to.

adenoma Cushing syndrome hyperaldosteronism primary aldosteronism

As listed by the trial registrant

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

Cushing's syndrome Hyperaldosteronism Hypercortisolism

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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