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

Who is this study for? Patients with Cushing Syndrome
What treatments are being studied? DOTATATE PET-CT+F-DOPA PET CT Scan+CT Scan+MRI
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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. ...

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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⁃ 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Raven N McGlotten, R.N.
mcglottenr@mail.nih.gov
(301) 827-0190
Backup
Lynnette K Nieman, M.D.
niemanl@mail.nih.gov
(301) 496-8935
Time Frame
Start Date: 2014-02-12
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Imaging
All subjects will be imaged
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov