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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

MR Images

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

David Woodrum, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

09-000864

NCT ID:

NCT01630239

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Soft Tissue Tumors
  • Liver Neoplasms
  • Soft Tissue Neoplasms

Name

Location
Mayo Clinic Rochester, Minnesota  55905