Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00721929
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 105
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.

Condition or Disease	Intervention/Treatment	Phase
Adrenal Gland Disease	Procedure: MRI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: adrenal mass group	Procedure: MRI; Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures

1. Diagnosis of either benign or malignant adrenal mass on pathology [0-6 months]

   definitive diagnosis of adrenal mass

Secondary Outcome Measures

1. stability of growth of mass on follow up imaging [3-24 months]

   evidence for benign or malignant mass based on assessment of stability or growth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gisela Mueller, MD, Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT00721929
• Other Study ID Numbers: 2003-0148
• First Posted: Jul 25, 2008
• Last Update Posted: Dec 6, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Gisela Mueller, MD, Principal Investigator, University of Michigan: adrenal glands, adrenal masses
• Additional relevant MeSH terms: Adrenal Gland Diseases

Study Results

No Results Posted as of Dec 6, 2012