Back to resultsLipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Primary Purpose
Adrenal Gland Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Gland Disease focused on measuring adrenal glands, adrenal masses
Eligibility Criteria
Inclusion Criteria:
- Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type.
Exclusion Criteria:
- Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
- Pregnant patients or patients who are lactating.
- A patient who is claustrophobic and would require sedation to complete the MRI exam.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adrenal mass group
Arm Description
Outcomes
Primary Outcome Measures
Diagnosis of either benign or malignant adrenal mass on pathology
definitive diagnosis of adrenal mass
Secondary Outcome Measures
stability of growth of mass on follow up imaging
evidence for benign or malignant mass based on assessment of stability or growth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00721929
Brief Title
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Official Title
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Gland Disease
Keywords
adrenal glands, adrenal masses
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adrenal mass group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Diagnosis of either benign or malignant adrenal mass on pathology
Description
definitive diagnosis of adrenal mass
Time Frame
0-6 months
Secondary Outcome Measure Information:
Title
stability of growth of mass on follow up imaging
Description
evidence for benign or malignant mass based on assessment of stability or growth
Time Frame
3-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type.
Exclusion Criteria:
Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
Pregnant patients or patients who are lactating.
A patient who is claustrophobic and would require sedation to complete the MRI exam.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
We'll reach out to this number within 24 hrs