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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688038
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : September 15, 2017
BioTex, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Cancer Bone Metastases Procedure: Laser Ablation Procedure: Magnetic Resonance Thermal Imaging Phase 4

Detailed Description:

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.

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 a limited 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 and an X-ray. About one (1) month after the laser ablation, you will have a physical exam and a limited 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. The investigational part of this study involves using MRTI to check the effect of ablation on the tumor. Up to 24 participants will be enrolled in this study. All will be enrolled at M.D. Anderson.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone
Actual Study Start Date : May 13, 2008
Actual Primary Completion Date : September 12, 2017
Actual Study Completion Date : September 12, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Laser Ablation + MRTI
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.
Other Name: MRTI

Primary Outcome Measures :
  1. Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI [ Time Frame: 2 Years ]
    Magnetic resonance thermal imaging (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) during Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with tumor metastases to the skeleton who are referred to interventional radiology for percutaneous ablation
  2. Surgery is not a viable or desirable alternative therapy at the time of enrollment
  3. Radiation therapy has failed or not indicated or can be safely postponed
  4. Symptomatic or asymptomatic tumor size less than or equal to 3 cm in its largest diameter.
  5. Performance status is Eastern Cooperative Oncology Group 2 or better in adults
  6. Patient is able to undergo MRI
  7. Patients at least 18 years of age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688038

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BioTex, Inc.
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Principal Investigator: Kamran Ahrar, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00688038    
Other Study ID Numbers: 2007-0393
NCI-2011-00518 ( Registry Identifier: NCI CTRP )
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Bone Metastases
Laser Ablation
Magnetic Resonance Thermal Imaging
Laser Induced Thermal Therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes