Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001849
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
1999-11-03
Brief Title:
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
New Imaging Modalities in the Evaluation of Patients With Ectopic Cushings Syndrome
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 octreoscan using the conventional low dose of indium-111 pentetreotide The sensitivity and specificity of these imaging studies depends on anatomic alterations andor 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 fluorine-18 dihydroxyphenylalanine F-DOPA or use of a higher dose of indium-111 pentetreotide Octreoscan 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 Octreoscan Eligible patients participating in this arm of the study will have a second standard dose scan Others will receive a higher dose octreoscan instead
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-CH-0055 | OTHER | National Institutes of Health NIH Clinical Center | None |