Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening
Primary Purpose
Adrenal Gland Diseases, Adrenal Gland Neoplasms
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
I-131 Iodocholesterol
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Gland Diseases focused on measuring adrenal diseases
Eligibility Criteria
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.
Sites / Locations
- University of Texas M.D. Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037843
First Posted
May 23, 2002
Last Updated
February 20, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00037843
Brief Title
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening
Official Title
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 1988 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
University of Michigan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Gland Diseases, Adrenal Gland Neoplasms
Keywords
adrenal diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
I-131 Iodocholesterol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald A. Podoloff, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening
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