68Ga-DOTATATE PET/CT Imaging for Ectopic Cushing Syndrome
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
Recruiting
Phase 2Interventional Study
ACTHCushing's Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
80 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for
This trial is looking for adults aged 18 to 90 with ectopic Cushing syndrome. Participants will undergo various imaging tests to help locate the source of a hormone problem related to their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 90 years old.
I have been diagnosed with ectopic Cushing syndrome or may have it.
I can understand and sign a consent form.
I will use effective contraception if I am a woman of childbearing age.
I am willing to follow all study procedures.
I am available for the duration of the study.
You may not be able to join if
I am pregnant or breastfeeding.
I have a severe active infection.
I have serious heart or blood issues.
I have significantly low blood counts or liver problems.
I weigh more than 136 kg.
I had more than 450 ml of blood taken in the last six weeks.
I have had ten or more F-DOPA PET/CT scans or DOTATATE scans.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imagi…
Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard dose of indium- 111 pentetreotide (\[111In-DTPA-D-Phe\]-pentetreotide). The sensitivity and specificity of structurally based imaging studies depends on anatomic alterations and the size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand imaging detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests the ability of \[18F\]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET, and the somatostatin imaging analogue, 68Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.
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Eligibility Criteria
* 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: agre…
* 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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