Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

NCT ID: NCT00037843

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1988-12-31
• Study Completion Date: 2007-08-31

Brief 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.

Conditions

Adrenal Gland Diseases; Adrenal Gland Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

I-131 Iodocholesterol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald A. Podoloff, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

NUM88-001

Identifier Type: -

Identifier Source: org_study_id