Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome
Status:
Recruiting
Trial end date:
2030-12-31
Target enrollment:
Participant gender:
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 ([(111)In-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
(like octreotide) imaging detect pathologic tissue based on physiologic and biochemical
processes within the abnormal tissue. This protocol tests the ability of
[(18)F]-L-3,4-dihydroxyphenylalanine ((18)F-DOPA) PET, Octreoscan and another somatostatin
imaging analogue, (68)Ga-DOTATATE-PET, to localize the source of ectopic ACTH production. The
study also examines whether administration of the glucocorticoid antagonist mifepristone can
improve the sensitivity of the (68)Ga-DOTATATE PET/CT.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)