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

Conditions

• ACTH
• Cushing's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• DOTATATE PET-CT — RADIATION
  68Ga-DOTATATE PET/CT
• F-DOPA PET CT — RADIATION
  68Ga-DOTATATE PET/CT
• CT scan — RADIATION
  routine CT scan
• Routine MRI scan — DIAGNOSTIC_TEST
  routine 1.5 or 3T MRI scan
• Gated MRI scan — DIAGNOSTIC_TEST
  Cardiac gated MRI scan
• 68Ga-DOTATATE — DRUG
  68Ga-DOTATATE radioligand
• 18F-DOPA — DRUG
  18F-DOPA radioligand

Study Details

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 Dates

Start date

Feb 12, 2014

Status verified

May 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Imaging
  All subjects will be imaged

Primary Outcome Measure

To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity. [ Time Frame: 6-12 months ]

Central Contacts

• Raven N McGlotten, R.N.
  (301) 827-0190
  [email protected]
• Lynnette K Nieman, M.D.
  (301) 496-8935
  [email protected]

Locations (1)

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