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New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome


N/A
18 Years
90 Years
Open (Enrolling)
Both
Cushing Syndrome

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Trial Information

New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome


Between 10 percent and 20 percent of patients with hypercortisolism (Cushing syndrome) have
ectopic production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In
approximately 50 percent of these patients, the source of ACTH cannot be found despite very
detailed and extensive examination including imaging studies such as computed tomography
scanning, magnetic resonance imaging, and octreotide scan using the conventional low dose of
indium-111 pentetreotide ([(111)In-DTPA-D-Phe]-pentetreotide). The sensitivity and
specificity of these imaging studies depends on anatomic alterations and/or the dose and
adequate uptake of radiopharmaceutical. In contrast, positron emission tomography (PET) has
the ability to detect pathologic tissue based on physiologic and biochemical processes
within the abnormal tissue. This protocol tests whether [18F]-L-3,4-dihydroxyphenylalanine
(18F-DOPA) or use of a higher dose of [111In-DTPA-D-Phe]-pentetreotide can be used to
localize successfully the source of ectopic ACTH production. In addition the study examines
whether administration of the glucocorticoid antagonist mifepristone can improved the
sensitivity of the standard dose [111 In-DTPA-D-Phe] pentetreotide. Patients participating
in this arm of the study will have a second standard dose scan rather than a higher dose
scan.

Inclusion 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.

Children (age less than18) are excluded.

Patients with any severe active infection.

Patients with 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).

Patients with impaired mental capacity or markedly abnormal psychiatric evaluation that
precludes informed consent.

Patients with body weight over 136 kg, which is the limit for the tables used in the
scanning areas.

Patients with combined blood withdrawal, during the six weeks preceding the study, of
greater than 450 ml.

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

Patients more than 70 years of age due to other possible existing diseases which may
significantly affect appropriate initial work-up and post-operative morbidity and
mortality.

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

Patients taking medications that alter CYP3A4 activity will not be eligible for the
mifepristone study, since this P450 system metabolizes mifepristone.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Lynnette K Nieman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Authority:

United States: Federal Government

Study ID:

990055

NCT ID:

NCT00001849

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Cushing Syndrome
  • PET
  • (18F)-DOPA
  • Pentetreotide
  • ACTH
  • Octreotide
  • Ectopic Cushing Syndrome
  • Cushing Syndrome
  • Cardiac Complexes, Premature

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892