NCT00037843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 1988

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1988

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2002

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

18.7 years

First QC Date

May 23, 2002

Last Update Submit

February 20, 2012

Conditions

Adrenal Gland DiseasesAdrenal Gland Neoplasms

Keywords

adrenal diseases

Interventions

I-131 IodocholesterolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adrenal Gland DiseasesAdrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Donald A. Podoloff, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2002

First Posted

May 24, 2002

Study Start

December 1, 1988

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

US(1)