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Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy
This study is currently recruiting participants.
Study NCT00688038   Information provided by M.D. Anderson Cancer Center
First Received: May 28, 2008   Last Updated: September 28, 2009   History of Changes

May 28, 2008
September 28, 2009
May 2008
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00688038 on ClinicalTrials.gov Archive Site
 
 
 
Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy
A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone

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).

Laser 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:

  • Your complete medical history will be recorded.
  • You will have a physical exam.
  • Blood (about 2 tablespoons) will be drawn to check how well the blood clots.
  • You will be asked questions about your ability to perform daily activities (performance status evaluation).
  • You will have a computed tomography (CT) scan and magnetic resonance imaging (MRI) to check the status of the disease.

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:

  • You will have an MRI.
  • Your skin will be cleaned and covered with sterile towels and sheets to lower the chance of an infection.
  • The doctor will use MRI scans to place a special needle (applicator) into the tumor. This applicator will be used to create heat at a high enough temperature that cells can be destroyed. Small masses may be destroyed in 1 treatment, but larger masses may require that the needle is placed several times. Each heating cycle takes less than 10 minutes.
  • During laser ablation, MRTI will be used to monitor the temperature within the ablation zone. The MRTI process is very similar to regular MRI.
  • Your heart rate and blood pressure will be measured during the entire procedure.
  • The entire procedure may take about 1-3 hours, depending on the size and location of your tumor.

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.

 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Advanced Cancer
  • Bone Metastases
  • Procedure: Laser Ablation
  • Procedure: Magnetic Resonance Thermal Imaging
Experimental: Magnetic resonance thermal imaging = MRTI
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
 
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kamran Ahrar, MD 713-745-4795
United States
 
NCT00688038
Kamran Ahrar, MD/Associate Professor, U.T.M.D. Anderson Cancer Center
2007-0393
M.D. Anderson Cancer Center
BioTex, Inc.
Principal Investigator: Kamran Ahrar, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP