Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

Adrenal Gland Disease Clinical Trial

Official title:

Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721929
• Other study ID #: 2003-0148
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: December 4, 2012
• Start date: October 2003
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Gland Disease
• Adrenal Gland Diseases

Intervention

Procedure:
• MRI
Magnetic Resonance Imaging

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of either benign or malignant adrenal mass on pathology	definitive diagnosis of adrenal mass	0-6 months	No
Secondary	stability of growth of mass on follow up imaging	evidence for benign or malignant mass based on assessment of stability or growth	3-24 months	No