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MR-Guided Laser Ablation of Hepatic Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630239
First Posted: June 28, 2012
Last Update Posted: May 5, 2015
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.
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
  Purpose
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

Condition Intervention Phase
Soft Tissue Tumors Procedure: Laser ablation Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by David A. Woodrum, Mayo Clinic:

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

Enrollment: 1
Study Start Date: June 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visualise Thermal Therapy System Procedure: Laser ablation
Laser ablation of hepatic tumors

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01630239


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

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01630239     History of Changes
Other Study ID Numbers: 09-000864
First Submitted: June 22, 2012
First Posted: June 28, 2012
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
Neoplasms
Digestive System Diseases
Liver Diseases