Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions

Liver Cancer Clinical Trial

Official title:

Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527891
• Other study ID #: 2003-1051
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2007
• Last updated: July 30, 2012
• Start date: June 2004

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Primary Objective:

1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the detection and evaluation of liver lesions.

Description:

Magnetic resonance imaging is taken with scanners at different magnetic field strength. The current practice at UTMDACC is to perform these exams at 1.5 Tesla. Tesla is the unit of strength of the magnetic field. This study will compare the images taken at the standard 1.5 Tesla (T) magnetic field with those at the newer 3.0T magnetic field.

You are already scheduled to receive a standard 1.5 T MR of the liver area as requested by your doctor. As part of this study, you will then be asked to return on a separate date to have a similar exam performed with the Signal 3.0T Excite MR scanner. You will return within a two week period from the date of your first MRI examination. The examination will be performed in a machine that looks similar to the 1.5T scanner. It will also take about the same amount of time as the examination at 1.5T.

The images taken by both scanners will be evaluated and compared. After you have had the second scan, your participation in this study will be over. If there are new findings identified with the new scan your doctor will be notified.

This is an investigational study. The 3.0T scan will be performed free of charge. A total of 20 patients will take part in this study All will be enrolled at UTMDACC.

This protocol is partially funded by a research grant from General Electric Medical Systems (GEMS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with a liver lesion larger than 1cm detected by a prior imaging modality.

2. Patients have been scheduled and are eligible for an MRI of the abdomen or MRI of the liver or MRI of the kidney examination.

Exclusion Criteria:

1) Patients who are unable to cooperate with breath hold.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• Signa Excite 3.0 T MRI Scan
Signa Excite 3.0 T MRI scan within a two week period from the date of receiving standard 1.5 T MR of the liver area.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

External Links

•   UT MD Anderson Cancer Center Website