MR-Guided Laser Ablation of Hepatic Tumors

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Soft Tissue Tumors

Treatments: Procedure: Laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01630239

09-000864

Details and patient eligibility

About

This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Visualise Thermal Therapy System

Experimental group

Treatment:

Procedure: Laser ablation