New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
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|ClinicalTrials.gov Identifier: NCT00001849|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : January 6, 2020
Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of ACTH in the pituitary gland.
Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as CT scans, MRIs, and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation.
Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue.
This study will test whether [18-F]-fluorodeoxyglucose (FDG) or use of a higher dose of [111In-DTPA-D-Phe]-pentetreotide can be used to successfully localize the source of ectopic ACTH production.<TAB>
|Condition or disease||Intervention/treatment||Phase|
|Cushing Syndrome Endocrine Disease||Drug: Pentetreotide Drug: 18F-DOPA||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome|
|Study Start Date :||February 26, 1999|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||April 26, 2019|
- Drug: Pentetreotide
Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5
- Drug: 18F-DOPA
F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography.
- Sensitivity, specificity and diagnostic accuracy of imaging modalities for the detection of ACTH-secreting non-pituitary tumor [ Time Frame: every 6 - 24 months ]identification of a tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001849
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Lynnette K Nieman, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|