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New PET scans could unmask hidden tumors in rare hormone disorder

NCT ID NCT02019706

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study compares advanced PET scans (68Ga-DOTATATE and F-DOPA) with standard imaging to locate hidden tumors causing ectopic Cushing syndrome. About 80 adults with this condition will undergo multiple scans over time. The goal is to see which scan or combination best finds the tumor source, potentially improving diagnosis and treatment.

What this could mean

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

Active substance
68Ga-DOTATATE and 18F-DOPA radioligands
What this could lead to
If successful, this could help doctors find hidden tumors in people with ectopic Cushing syndrome, leading to more targeted treatment.
What could go wrong
This is a Phase 2 study with only 80 participants, so results may not apply to everyone. The imaging techniques may not find all tumors, and radiation exposure is a minor 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

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

Feb 2014

Expected to finish

Dec 2030

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 80 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 of the following criteria: * 18 - 90 years of age * Medical history of ectopic Cushing syndrome or diagnosed with the possibility of ectopic Cushing syndrome * For females of reproductive potential: agreement to use highly effective contraception for at least 2 weeks before any PET scan * Ability of subject to understand and the willingness to sign a written informed consent document * Stated willingness to comply with all study procedures and availability for the duration of the study EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnancy or lactation; the radiation associated with PET and CT scans may be harmful to a developing fetus. Likewise the ingestion of radionuclides in breast milk has an unknown risk to an infant. * Evidence of severe active infection * Clinically significantly impaired cardiovascular function, abnormal coagulation in the absence of medically-indicated treatment (PT and PTT elevated by 30% above the normal values), hematopoietic (hematocrit less than 30%, hemoglobin below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm\^3), hepatic (liver enzymes elevated by 4-fold above normal values), or renal function (plasma creatinine level over 2.1). * Based on the clinical judgment of the attending physician, other medical problems may prompt exclusion. * Body weight over 136 kg, which is the limit for the tables used in the scanning areas. * Combined blood withdrawal during the six weeks preceding the study greater than 450 ml. * Subjects who previously underwent ten or more F-DOPA PET/CT scans and ten or more DOTATATE scans.

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Conditions

The condition(s) this trial relates to.

Cushing syndrome ectopic Cushing syndrome

As listed by the trial registrant

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

ACTH Cushing's syndrome

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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