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
Results First Posted : January 25, 2021
Last Update Posted : April 14, 2021
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 corticotropin (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 computed tomography (CT) scans, magnetic resonance imaging (MRI), 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 fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
|Condition or disease||Intervention/treatment||Phase|
|Cushing Syndrome Endocrine Disease||Drug: Pentetreotide Drug: 18F-DOPA Device: CT scan Device: MRI Drug: 18-FDG||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Comparison of results in patients receiving similar imaging scans|
|Masking:||None (Open Label)|
|Official Title:||New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome|
|Actual Study Start Date :||May 20, 1999|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||April 26, 2019|
Experimental: Patients with Cushing Syndrome
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.
Other Name: [111In-diethylenetriaminepentaacetic acid-D-Phe]-pentetreotide
18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography (PET). Limited to 3 doses over the course of the study.
Device: CT scan
CT scan of chest, abdomen, neck and /or pelvis
Other Name: computed tomography scan
MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis
Other Name: magnetic resonance imaging scan
FDG PET scan of body
Other Name: 18-fluorine fluorodeoxyglucose PET scan
- Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients [ Time Frame: six months or less ]The percentage of patients in whom imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or in which imaging identified a recurrence at a site of previous resection.
- Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions [ Time Frame: six months or less ]The percentage of lesions for which imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or for which imaging identified a recurrence at a site of previous resection.
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)|