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| 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 |
| 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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Hide Detailed DescriptionLaser ablation is designed to destroy tumor tissue with the use of fiber optics that are placed directly into the tumor to deliver laser light energy into the tissue.
In this study, tumor destruction will be checked using MRTI. MRTI is very similar to other MRI techniques, but instead of providing imaging data, MRTI will provide temperature data for cancerous areas in the body during the laser ablation process. If tumor temperature can be measured more accurately, the laser ablation process may be safer.
Screening Tests:
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
Laser Ablation and the MRTI Scan:
If you are found to be eligible to take part in this study, on the day you have laser ablation, you will have an intravenous (IV) line placed. You will receive sedation or general anaesthesia (drugs to make you sleep) through a needle in your vein over 1-3 hours to lessen any pain you may have during the procedure. This process will be explained to you.
After receiving the anaesthesia, the following tests and procedures will be performed:
After the procedure is completed, you will be kept in the hospital for 4-6 hours for observation. You will be checked for recovery from the sedation that you received during the procedure. Once you have recovered from the procedure, you will be allowed to leave the hospital. If you have side effects from the procedure, the doctor may decide to keep you in the hospital for a longer time period for observation.
Follow-Up Visits:
After you have completed the procedure, you will return to M. D. Anderson for follow-up visits. About one (1) week after the laser ablation, you will have a physical exam. About one (1) month after the laser ablation, you will have a physical exam and an MRI to check the status of the disease.
Length of Study:
You will be considered off-study after the 1-month follow up visit.
This is an investigational study. The laser ablation procedure is an FDA-approved procedure. The devices are commercially available and can be used outside research studies.Up to 24 participants will be enrolled in this study. All will be enrolled at M.D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kamran Ahrar, MD | 713-745-4795 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Kamran Ahrar, MD | |
| Principal Investigator: | Kamran Ahrar, MD | U.T.M.D. Anderson Cancer Center |
More Information
| 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 |
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Advanced Cancer Bone Metastases Laser Ablation Magnetic Resonance Thermal Imaging |
Laser Induced Thermal Therapy MRTI LITT |
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Neoplastic Processes Neoplasms Neoplasms by Site Pathologic Processes Musculoskeletal Diseases |
Bone Neoplasms Hematologic Diseases Neoplasm Metastasis Bone Marrow Diseases Bone Diseases |