Search / Trial NCT00001453

Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Petrosal Sinus Sampling Corticotropin Releasing Hormone Cushing Syndrome Internal Jugular Vein Sampling Corticotropin Releasing Hormone Stimulation

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 h...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Patients with the following characteristics may be included in the protocol:
  • Age 18-75 years.
  • Evidence of Cushing syndrome. Evidence to suggest overactivity of the hypothalamic-pituitary-adrenal axis, such as increased urinary excretion of glucocorticoids or lack of suppressibility with low doses of dexamethasone in conjunction with clinical features, will be sought prior to admission.
  • EXCLUSION CRITERIA:
  • Patients will be excluded from entry to the protocol if:
  • A clear-cut pituitary tumor is present on T1-weighted conventional pituitary MR scan.
  • There is any contraindication to catheterization. Patients with known reaction to contrast material will be excluded from this elective study if they have a strong history of previous contrast media reaction and cannot be studied safely by giving medical prophylaxis before the procedure.
  • The patient is pregnant.
  • Combined blood withdrawal during the six weeks preceding the study exceeds 450 ml, or if hematocrit at entry is less than 33%.
  • Because of the increased risk of morbidity caused by contrast dyes in patients with a renal dysfunction, patients with a creatinine greater than 1.3 mg/dl will be excluded.
  • Patients with a diastolic blood pressure persistently greater than 100 mm Hg (with or without medication) will be excluded from sampling procedures.
  • They have had radiation exposure during the previous year that represents a significant additive risk in combination with the expected doses in this protocol. Patients and their doctors will be questioned about their exposure to radiation before they are accepted into the protocol.
  • For the questionnaire only, patients who do not speak and read English will be excluded. This instrument has not been validated in non-English speakers.

Attachments

readout_NCT00001453_2024-06-14.pdf

4.5 MB

NCT00001453_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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