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RECRUITING
NCT02019706
PHASE2

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

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2014-02-12

Completion Date

2030-12-31

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

RADIATION

DOTATATE PET-CT

68Ga-DOTATATE PET/CT

RADIATION

F-DOPA PET CT

68Ga-DOTATATE PET/CT

RADIATION

CT scan

routine CT scan

DIAGNOSTIC_TEST

Routine MRI scan

routine 1.5 or 3T MRI scan

DIAGNOSTIC_TEST

Gated MRI scan

Cardiac gated MRI scan

DRUG

68Ga-DOTATATE

68Ga-DOTATATE radioligand

DRUG

18F-DOPA

18F-DOPA radioligand

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States