MR-Guided Laser Ablation of Hepatic Tumors

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:
NCT01630239
First received: June 22, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Mayo Clinic:

Primary Outcome Measures:
  • MR Images [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01630239

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie L 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: NCT01630239     History of Changes
Other Study ID Numbers: 09-000864
Study First Received: June 22, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014