Back to resultsMR-Guided Laser Ablation of Hepatic Tumors
Primary Purpose
Soft Tissue Tumors
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laser ablation
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Tumors
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Visualise Thermal Therapy System
Arm Description
Outcomes
Primary Outcome Measures
MR Images
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01630239
Brief Title
MR-Guided Laser Ablation of Hepatic Tumors
Official Title
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visualise Thermal Therapy System
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laser ablation
Intervention Description
Laser ablation of hepatic tumors
Primary Outcome Measure Information:
Title
MR Images
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Woodrum, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MR-Guided Laser Ablation of Hepatic Tumors
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