Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

Adrenal Gland Neoplasms Clinical Trial

Official title:

Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037843
• Other study ID #: NUM88-001
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2002
• Last updated: February 20, 2012
• Start date: December 1988
• Est. completion date: August 2007

Study information

• Verified date: February 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical research study using I-131 Iodocholesterol which is an experimental radioactive chemical that when injected into the vein, is picked up in the adrenal glands and permits visualization with gamma imaging devices. These images are used in diagnosing a variety of adrenal abnormalities.Prior to the injection of I-131 Iodocholesterol, the patient will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this is deemed important. The patient will continue to take these capsules throughout the period of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given into a vein and the patient will return for images on at least 1 and possibly 2 occasions between 3-7 days after injection. If the case requires it, the patient may also be given a steroid in tablet form, dexamethasone, to take orally prior to and after the injection to suppress normal adrenal function so that the abnormal tissues can be more easily detected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Gland Diseases
• Adrenal Gland Neoplasms

Intervention

Drug:
• I-131 Iodocholesterol

Locations

Country	Name	City	State
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	University of Michigan

Country where clinical trial is conducted

United States,