Prospective Use of Real-time MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01644578
First received: July 17, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.


Condition Intervention
Evaluate the Role of Real-time Imaging in Needle Placement.
Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging.
Procedure: Real-time imaging for MRI-guided procedures

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Use of Real-time MRI

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Determine the time required for each step for needle placement [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine ease of use of the software [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Real-time imaging for MRI-guided procedures
Real-time imaging for improvement of workflow in MRI-guided procedures
Procedure: Real-time imaging for MRI-guided procedures
Real-time imaging for improvement of workflow in MRI-guided procedures

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for a percutaneous MR guided procedure

Exclusion Criteria:

  • Pregnant Women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644578

Locations
United States, Minnesota
Mayo Clinic in Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sathre    507-538-0540    sathre@mayo.edu   
Principal Investigator: David A. Woodrum, M.D., Ph.D         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Woodrum, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01644578     History of Changes
Other Study ID Numbers: 09-005887
Study First Received: July 17, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
MRI
real-time imaging
workflow

ClinicalTrials.gov processed this record on September 30, 2014