Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening
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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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.
Contacts and Locations| United States, Texas | |
| University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 Neoplasms |
Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013