Clinical Trial: Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Internal Jugular Vein Sampling for ACTH Levels for the Differential Diagnosis of Cushing Syndrome

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 Cushing's 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 ju

Detailed Summary:

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 Cushing's 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
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: November 3, 1999
Date Started: April 10, 1995
Date Completion: October 20, 2014
Last Updated: April 19, 2017
Last Verified: October 20, 2014