MR-Guided Laser Ablation of Hepatic Tumors

Soft Tissue Tumors Clinical Trial

Official title:

Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630239
• Other study ID #: 09-000864
• Status: Completed
• Phase: Phase 0
• First received: June 22, 2012
• Last updated: May 1, 2015
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Soft Tissue Neoplasms
• Soft Tissue Tumors

Intervention

Procedure:
• Laser ablation
Laser ablation of hepatic tumors

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MR Images		6 months	Yes