Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00037843
First received: May 23, 2002
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Adrenal Gland Diseases
Adrenal Gland Neoplasms
Drug: I-131 Iodocholesterol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 114
Study Start Date: December 1988
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037843

Locations
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
University of Michigan
Investigators
Principal Investigator: Donald A. Podoloff, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00037843     History of Changes
Other Study ID Numbers: NUM88-001
Study First Received: May 23, 2002
Last Updated: February 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
adrenal diseases

Additional relevant MeSH terms:
Adrenal Gland Diseases
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2014