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

June 22, 2012
June 28, 2012
May 5, 2015
June 2012
March 2015   (Final data collection date for primary outcome measure)
MR Images [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01630239 on Archive Site
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MR-Guided Laser Ablation of Hepatic Tumors
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.
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Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Soft Tissue Tumors
Procedure: Laser ablation
Laser ablation of hepatic tumors
Experimental: Visualise Thermal Therapy System
Intervention: Procedure: Laser ablation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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David A. Woodrum, Mayo Clinic
Mayo Clinic
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Principal Investigator: David Woodrum, MD, PhD Mayo Clinic
Mayo Clinic
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP