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

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.

Conditions

• ACTH
• Cushing's Syndrome

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Lynnette K Nieman, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-12

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Drug

Yes

Countries

• United States

Study Locations