Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gisela Mueller, MD, University of Michigan

ClinicalTrials.gov Identifier:

NCT00721929

First received: July 23, 2008

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2008
Last Updated Date	December 4, 2012
Start Date ^ICMJE	October 2003
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 4, 2012)	Diagnosis of either benign or malignant adrenal mass on pathology [ Time Frame: 0-6 months ] [ Designated as safety issue: No ] definitive diagnosis of adrenal mass
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00721929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 4, 2012)	stability of growth of mass on follow up imaging [ Time Frame: 3-24 months ] [ Designated as safety issue: No ] evidence for benign or malignant mass based on assessment of stability or growth
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Official Title ^ICMJE	Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Brief Summary	The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Adrenal Gland Disease
Intervention ^ICMJE	Procedure: MRI Magnetic Resonance Imaging
Study Arm (s)	Experimental: adrenal mass group Intervention: Procedure: MRI
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	July 2012
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00721929
Other Study ID Numbers ^ICMJE	2003-0148
Has Data Monitoring Committee	Not Provided
Responsible Party	Gisela Mueller, MD, University of Michigan
Study Sponsor ^ICMJE	University of Michigan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Michigan
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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