MR-Guided Laser Ablation of Hepatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630239
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic

Brief Summary:
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

Condition or disease Intervention/treatment Phase
Soft Tissue Tumors Procedure: Laser ablation Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors
Study Start Date : June 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Visualise Thermal Therapy System Procedure: Laser ablation
Laser ablation of hepatic tumors

Primary Outcome Measures :
  1. MR Images [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment.
  • Surgery is not a viable or desirable alternative therapy at the time of enrollment
  • Radiation therapy has failed or not indicated or can be safely postponed
  • Tumor size ≤ 5 cm at its largest diameter
  • Tumor position is not in the central liver hilum
  • Performance status is ECOG 2 or better in adults
  • Patient is able to undergo MRI

Exclusion Criteria:

  • Patients with pacemaker or defibrillator
  • Patients with metallic surgical clips close to the site of the intended ablation
  • Pregnant women
  • Patients with hilar liver lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01630239

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: David Woodrum, MD, PhD Mayo Clinic

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic Identifier: NCT01630239     History of Changes
Other Study ID Numbers: 09-000864
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Liver Neoplasms
Soft Tissue Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases