Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001453
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
1999-11-03
Brief Title:
Jugular Vein Sampling for Hormone Levels for the Diagnosis of 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:
Internal Jugular Vein Sampling for ACTH Levels for the Differential Diagnosis of Cushing Syndrome
Status:
COMPLETED
Status Verified Date:
2014-10-20
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:
Patients with Cushing disease have hormone producing tumors in their pituitary gland Often these tumors are so small they cannot be detected by magnetic resonance imaging MRI The inferior petrosal sinuses are small veins that drain the blood from the pituitary gland By taking a small sample of blood from these sinuses doctors can differentiate a small tumor in the pituitary gland from other tumors in the body producing the hormone Patients with Cushing disease have high levels of the hormone ACTH in the petrosal sinuses Patients with other causes of Cushing syndrome do not have increased levels of ACTH in the petrosal sinuses
The procedure to collect blood from the petrosal sinus is called Inferior Petrosal Sinus Sampling IPSS The technique is very sensitive and can tell the difference between a pituitary tumor and other causes of Cushing syndrome nearly 100 of the time However IPSS is very difficult to perform and is only available in a few hospitals Therefore researchers are looking for another possible way to diagnose Cushing syndrome that would be less technically difficult and more readily available to patients
ACTH is produced in the pituitary gland as a response to the production of Corticotropin-Releasing Hormone CRH in the brain hypothalamus This study will compare ACTH levels in the internal jugular veins before and after CRH stimulation with those obtained by conventional IPSS from patients with Cushings syndrome
Obtaining blood from the jugular veins is a simple practically risk free procedure that could be done easily in a community hospital on an out patient basis Researchers believe that CRH stimulation will increase ACTH production from tumors of the pituitary gland corticotroph adenomas so that the diagnostic information from jugular venous sampling would be equivalent to that of IPSS
This proposal to develop jugular venous sampling JVS with CRH stimulation as a test for the differential diagnosis of Cushing Syndrome would potentially contribute greatly to the medical care of patients with Cushing syndrome as a less costly safer and more widely available alternative to IPSSTAB
The procedure to collect blood from the petrosal sinus is called Inferior Petrosal Sinus Sampling IPSS The technique is very sensitive and can tell the difference between a pituitary tumor and other causes of Cushing syndrome nearly 100 of the time However IPSS is very difficult to perform and is only available in a few hospitals Therefore researchers are looking for another possible way to diagnose Cushing syndrome that would be less technically difficult and more readily available to patients
ACTH is produced in the pituitary gland as a response to the production of Corticotropin-Releasing Hormone CRH in the brain hypothalamus This study will compare ACTH levels in the internal jugular veins before and after CRH stimulation with those obtained by conventional IPSS from patients with Cushings syndrome
Obtaining blood from the jugular veins is a simple practically risk free procedure that could be done easily in a community hospital on an out patient basis Researchers believe that CRH stimulation will increase ACTH production from tumors of the pituitary gland corticotroph adenomas so that the diagnostic information from jugular venous sampling would be equivalent to that of IPSS
This proposal to develop jugular venous sampling JVS with CRH stimulation as a test for the differential diagnosis of Cushing Syndrome would potentially contribute greatly to the medical care of patients with Cushing syndrome as a less costly safer and more widely available alternative to IPSSTAB
Detailed Description:
Sampling from the inferior petrosal sinuses for ACTH levels differentiates Cushing disease from the ectopic ACTH syndrome in nearly all patients Patients with corticotroph tumors have a petrosal-to-peripheral ACTH gradient of 2 or more while patients with other causes of Cushing syndrome have lower gradients Bilateral petrosal sinus sampling also often provides useful information on lateralization of the adenoma for the neurosurgeon The widespread application of inferior petrosal sinus sampling has been limited by concerns about potential complications and by technical failures in the hands of less experienced radiologists In this protocol we compare ACTH levels in the internal jugular veins before and after CRH stimulation with those obtained by conventional inferior petrosal sinus sampling from patients with Cushings syndrome Obtaining blood from the jugular veins is a simple practically risk-free procedure that could be accomplished easily in community hospitals on an outpatient basis We hypothesize that corticotropin-releasing hormone CRH stimulation will increase ACTH production from corticotroph adenomas so that the diagnostic information from jugular venous sampling would be equivalent to that obtained by catheterization of the petrosal sinuses
Currently fewer than ten centers in the United States have sufficient technical expertise with inferior petrosal sinus sampling IPSS to ensure reliable results This proposal to develop jugular venous sampling JVS with CRH stimulation as a test for the differential diagnosis of Cushing syndrome would potentially contribute greatly to the medical care of patients with Cushing syndrome as a less costly safer and more widely available alternative to inferior petrosal sinus sampling Initial data from 35 patients undergoing both JVS and IPSS revealed no technical problems with either procedure IPSS correctly identified 2831 patients with Cushing disease while JVS correctly identified 23 of these patients using conventional criteria petrosalperipheral greater than 2 before or 3 after CRH administration Thus JVS may be a useful initial procedure at institutions where IPSS is not available However since it is likely that jugularperipheral ratios will be lower in patients with ectopic ACTH secretion so far 12 - 204 the protocol evaluates also the performance of JVS in patients with ectopic ACTH secretion to determine whether the criteria for interpretation of JVS should be different than those used for IPSS
Currently fewer than ten centers in the United States have sufficient technical expertise with inferior petrosal sinus sampling IPSS to ensure reliable results This proposal to develop jugular venous sampling JVS with CRH stimulation as a test for the differential diagnosis of Cushing syndrome would potentially contribute greatly to the medical care of patients with Cushing syndrome as a less costly safer and more widely available alternative to inferior petrosal sinus sampling Initial data from 35 patients undergoing both JVS and IPSS revealed no technical problems with either procedure IPSS correctly identified 2831 patients with Cushing disease while JVS correctly identified 23 of these patients using conventional criteria petrosalperipheral greater than 2 before or 3 after CRH administration Thus JVS may be a useful initial procedure at institutions where IPSS is not available However since it is likely that jugularperipheral ratios will be lower in patients with ectopic ACTH secretion so far 12 - 204 the protocol evaluates also the performance of JVS in patients with ectopic ACTH secretion to determine whether the criteria for interpretation of JVS should be different than those used for IPSS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 95-CH-0104 | None | None | None |