MR-Guided Laser Ablation of Hepatic Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01630239
First received: June 22, 2012
Last updated: May 1, 2015
Last verified: May 2015

June 22, 2012
May 1, 2015
June 2012
March 2015   (final data collection date for primary outcome measure)
MR Images [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01630239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01630239
09-000864
No
David A. Woodrum, Mayo Clinic
Mayo Clinic
Not Provided
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