New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00001849
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Public title: New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
• Scientific title: New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome
• Date of first enrolment: February 26, 1999
• Target sample size: 98
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00001849
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

All eligible patients are invited to participate in this protocol. Patients are adults with
possible ectopic Cushing syndrome. Since both men and women are affected with ectopic
Cushing syndrome, both sexes are studied. All ethnic and racial groups are at risk and will
be included. Patients must be willing to return to NIH for follow-up studies.

EXCLUSION CRITERIA:

Pregnant or lactating women. A pregnancy test is performed in women of childbearing
potential (up to age 55) unless they have a history of hysterectomy.

Children (age less than18) 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.

Patients taking medications that alter CYP3A4 activity will not be eligible for the
mifepristone study, since this P450 system metabolizes mifepristone. Such participants
would receive a clinical H-OCT instead, if the L-OCT were negative. Patients with
hypokalemia (K < 3.5 mEq/L), despite medical therapy with replacement or mineralocorticoid
antagonists will also be excluded from the mifepristone studies.

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 or leg edema, and
blood pressure over 190/100), abnormal coagulation (PT and PTT elevated by 30 percent
above the normal values), hematopoietic (hematocrit less than 30 percent, hemoglobin
below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm(3)),
hepatic (liver enzymes elevated by 3-fold above normal values) or renal function
(plasma creatinine level over 2.0).

- impaired mental capacity or markedly abnormal psychiatric evaluation 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, of greater than
450 ml.

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

- strong evidence for Cushing disease. This includes those with positive IPSS or a
lesion on pituitary MRI.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cushing Syndrome

Endocrine Disease

Intervention(s)

Drug: 18F-DOPA

Drug: Pentetreotide

Primary Outcome(s)

Sensitivity, specificity and diagnostic accuracy of imaging modalities for the detection of ACTH-secreting non-pituitary tumor [Time Frame: every 6 - 24 months]

Secondary ID(s)

990055

99-CH-0055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors