Actively Recruiting
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
80
Participants Needed
1
Research Sites
880 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Medical history or diagnosis suggesting ectopic Cushing syndrome
- For females who can have children: agreement to use highly effective contraception for at least 2 weeks before any PET scan
- Ability to understand and willingness to sign informed consent
- Willingness to comply with all study procedures and be available for the study duration
You will not qualify if you...
- Pregnancy or breastfeeding
- Severe active infection
- Significant heart problems or abnormal blood clotting without treatment
- Blood disorders (hematocrit less than 30%, hemoglobin below 10 g/dl, white blood count below 3000 K/UL, platelets below 100,000 K/mm3)
- Liver enzyme levels more than 4 times normal
- Kidney function with plasma creatinine over 2.1
- Other medical problems as judged by the doctor
- Body weight over 136 kg
- Blood drawn more than 450 ml in the 6 weeks before the study
- Having had 10 or more previous F-DOPA PET/CT scans and 10 or more DOTATATE scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
R
Raven N McGlotten, R.N.
CONTACT
L
Lynnette K Nieman, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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