New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001849|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 19, 2017
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||Drug: Pentetreotide Drug: 18-F-fluorodeoxyglucose Drug: (18F)-L-3,4-dihydroxyophenylalanine (18F-DOPA)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 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|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Sensitivity, specificity and diagnostic accuracy of imaging modalities for the detection of ACTH-secreting non-pituitary 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
|Contact: Raven N McGlotten, R.N.||(301) email@example.com|
|Contact: Lynnette K Nieman, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Lynnette K Nieman, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|