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Imaging for Ectopic Cushing Syndrome

This study is looking for better ways to find the source of ectopic Cushing syndrome, a condition where your body makes too much ACTH (a hormone) from a non-pituitary tumor. Currently, it's hard to find these tumors in about half of patients. Researchers are comparing different imaging tests: 68Ga-DOTATATE PET/CT, F-DOPA PET/CT, standard CT scans, and MRI scans. The goal is to see which test, or combination of tests, is best at finding these tumors. You can join if you are 18-90 years old and have been diagnosed with, or might have, ectopic Cushing syndrome. The study aims to find the most sensitive imaging technique and the best combination of tests within 6-12 months.

Study design
This is an interventional study involving 80 participants. It compares several imaging techniques to find the best way to diagnose ectopic Cushing syndrome.
What's involved
You would undergo various imaging tests, including 68Ga-DOTATATE PET/CT, F-DOPA PET/CT, routine CT scans, and routine or cardiac gated MRI scans.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the effectiveness of the imaging techniques at 6-12 months after the tests.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02019706

Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome

Recruiting
PHASE2Ages 18–80InterventionalDiagnostic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~80 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:DOTATATE PET-CTF-DOPA PET CTCT scanRoutine MRI scanGated MRI scan68Ga-DOTATATE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.
Measured over 6-12 months
+1 more outcome measured

Conditions

ACTH
Cushing's Syndrome

Explore related trials

Cushing Syndrome

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Lynnette K Nieman, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Raven N McGlotten, R.N.
[email protected]
(301) 827-0190
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.6-12 months

    Subjects will be imaged every 6-12 months until tumor is found

  • To determine if there is a combination of imaging tests with optimal diagnostic accuracy.6-12 months

    subjects will be imaged every 6-12 months until tumor is found