NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required


Population Exclusion(s)



Cushing's Syndrome;

Recruitment Keyword(s)



Cushing's Syndrome

Investigational Drug(s)


Investigational Device(s)



Radiation: F-DOPA PET CT
Radiation: CT scan
Diagnostic Test: Routine MRI scan
Diagnostic Test: Gated MRI scan
Drug: 18F-DOPA

Supporting Site

National Institute of Child Health and Human DevelopmentNational Institute of Diabetes and Digestive and Kidney Diseases

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.

--Back to Top--



- Adults with possible ectopic Cushing syndrome

-Age 18-80

- Patients must be willing to return to NIH for follow-up studies.


-Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) prior to each MRI or study involving radiation, unless they have a history of hysterectomy and/or bilateral oophorectomy.

-Children (age less than 18) are excluded. Because ectopic ACTH secretion is rare in this age group, the likelihood of benefit is less and does not balance the risk of radiation.

-Very elderly patients (> 90 years)

-For the mifepristone studies only: Patients taking medications that alter CYP3A4 activity will not be eligible for the mifepristone study, since this P450 system metabolizes mifepristone. Patients with hypokalemia (K < 3.5 mEq/L), despite medical therapy with replacement or mineralocorticoid antagonists will also be excluded from the mifepristone studies. Such patients may participate in other components of the protocol. Medications affecting CYP3A4 may be adjusted to allow participation in the mifepristone component, with a one week washout period.

-The presence of severe active infection.

-clinically significantly impaired cardiovascular (e.g. history of abnormally low ejection fraction, the presence of moderate pulmonary fluid overload, and/or blood pressure over 190/100), 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.

-impaired mental capacity or markedly abnormal psychiatric condition that precludes informed consent.

-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 450 ml.

-known allergy to [(111)In-DTPA-D-Phe]-pentetreotide or other somatostatin analogues.

-strong evidence for Cushing s disease. This includes those with a central to peripheral ACTH gradient during IPSS or a lesion on pituitary MRI. We anticipate that these exclusion criteria will increase the ratio of patients with ectopic ACTH syndrome to those with Cushing s disease from the usual 1: 8 to 1: 2, thus we would accrue 3 patients to identify one with ectopic ACTH secretion.

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Lynnette K. Nieman, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 1-3121
(301) 496-8935

Raven N. McGlotten, R.N.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
10 Center Drive
Bethesda, Maryland 20892
(301) 827-0190

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


--Back to Top--