Recruiting
Phase 2

Octreotide

Sponsor:

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

Code:

NCT02019706

Conditions

ACTH

Cushing's Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DOTATATE PET-CT

F-DOPA PET CT

CT scan

Routine MRI scan

Gated MRI scan

Study Details

Brief 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

Study ID

NCT02019706

Start date

Feb 12, 2014

Status verified date

May 8, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnancy or lactation; the radiation associated with PET and CT scans may be harmful to a developing fetus. Likewise the ingestion of radionuclides in breast milk has an unknown risk to an infant.
  • Evidence of severe active infection
  • Clinically significantly impaired cardiovascular function, abnormal coagulation in the absence of medically-indicated treatment (PT and PTT elevated by 30% above the normal values), hematopoietic (hematocrit less than 30%, hemoglobin below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm\^3), hepatic (liver enzymes elevated by 4-fold above normal values), or renal function (plasma creatinine level over 2.1).
  • Based on the clinical judgment of the attending physician, other medical problems may prompt exclusion.
  • Body weight over 136 kg, which is the limit for the tables used in the scanning areas.
  • Combined blood withdrawal during the six weeks preceding the study greater than 450 ml.
  • Subjects who previously underwent ten or more F-DOPA PET/CT scans and ten or more DOTATATE scans.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Imaging

All subjects will be imaged

Interventions

DOTATATE PET-CT

68Ga-DOTATATE PET/CT

F-DOPA PET CT

68Ga-DOTATATE PET/CT

CT scan

routine CT scan

Routine MRI scan

routine 1.5 or 3T MRI scan

Gated MRI scan

Cardiac gated MRI scan

68Ga-DOTATATE

68Ga-DOTATATE radioligand

18F-DOPA

18F-DOPA radioligand

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 ]
  • To determine if there is a combination of imaging tests with optimal diagnostic accuracy. [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Raven N McGlotten, R.N.

(301) 827-0190mcglottenr@mail.nih.gov

Lynnette K Nieman, M.D.

(301) 496-8935niemanl@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

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

Last update posted

Jul 8, 2026

Last verified

May 8, 2026

Keywords

  • DOTATATE
  • Cushing's Syndrome
  • Hypercortisolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-07-08.