MR-Guided Laser Ablation of Hepatic Tumors

May 1, 2015 updated by: David A. Woodrum, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visualise Thermal Therapy System
Procedure: Laser ablation
Laser ablation of hepatic tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MR Images
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-000864

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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