Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, September 2009

First Received: May 28, 2008 Last Updated: September 28, 2009 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	BioTex, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00688038

Purpose

The goal of this clinical research study is to learn how well magnetic resonance thermal imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser ablation (a procedure that uses lasers to create heat that is designed to destroy cancer cells).

During Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone, investigators will collect and analyze MRTI data to determine the correlation between observed temperatures determined from MRTI and the actual size of ablation as determined by post-ablation contrast-enhanced magnetic resonance imaging (MRI).

Condition	Intervention
Advanced Cancer Bone Metastases	Procedure: Laser Ablation Procedure: Magnetic Resonance Thermal Imaging

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn how well magnetic resonance thermal imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser ablation (a procedure that uses lasers to create heat that is designed to destroy cancer cells). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Laser Ablation + MRTI: Experimental Magnetic resonance thermal imaging = MRTI	Procedure: Laser Ablation Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor. Procedure: Magnetic Resonance Thermal Imaging MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with tumor metastases to the axial skeleton who are referred to interventional radiology for percutaneous ablation
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
Symptomatic or asymptomatic tumor size less than or equal to 3 cm in its largest diameter.
Performance status is ECOG 2 or better in adults
Patient is able to undergo MRI
Patients at least 18 years of age

Exclusion Criteria:

Patients with uncorrectable coagulopathy
Patients with pacemaker or defibrillator
Patients with metallic prosthesis at the site of the intended ablation
Patients with spinal cord compression or epidural tumor extension
Patients with vertebral body metastases exhibiting posterior wall destruction
Patients with any soft tissue extension of a vertebral tumor
Patients with any metastasis that is extrinsically located in vertebra or any long bones of the extremities compromising the cortex
Patients with tumors having direct extension or involvement of a joint capsule or a major nerve
Patients with Neutropenia (ANC less then 1000) or known active infection
Patients unable to undergo conscious sedation
Children under 18 years of age will be excluded from this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688038

Contacts

Contact: Kamran Ahrar, MD

713-745-4795

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kamran Ahrar, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

BioTex, Inc.

Investigators

Principal Investigator:

Kamran Ahrar, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Kamran Ahrar, MD/Associate Professor )
Study ID Numbers:	2007-0393
Study First Received:	May 28, 2008
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00688038 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Bone Metastases
Laser Ablation
Magnetic Resonance Thermal Imaging

Laser Induced Thermal Therapy
MRTI
LITT

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Neoplasms by Site
Pathologic Processes
Musculoskeletal Diseases

Bone Neoplasms
Hematologic Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Bone Diseases

ClinicalTrials.gov processed this record on November 05, 2009