MR-Guided Laser Ablation of Hepatic Tumors

Early Phase 1

Completed

• Conditions: Soft Tissue Tumors
• Interventions: Procedure: Laser ablation

• Registration Number: NCT01630239
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visualise Thermal Therapy System	Laser ablation	-

Primary Outcome Measures

Name	Time	Method
MR Images	6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States