MR-Guided Laser Ablation of Hepatic Tumors

This study is currently recruiting participants.
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
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 April 17, 2014