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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | March 26, 2009 | ||||
| Start Date ICMJE | January 2002 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ablation of tumor [ Time Frame: During procedure ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
A tumor can be completely ablated by ILT with MRI-guidance | ||||
| Change History | Complete list of historical versions of study NCT00207350 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patients undergoing ILT will be assessed pre- and post-operatively based on a neurological exam by a physician and patient self-assessment using the Glioma Outcomes Questionnaire [ Time Frame: 3 Months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Patients undergoing ILT will be assessed pre- and post-operatively based on a neurological exam by a physician and patient self-assessment using the Glioma Outcomes Questionnaire. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neurosurgical Use of Interstitial Laser Therapy (ILT) | ||||
| Official Title ICMJE | Neurosurgical Use of Interstitial Laser Therapy (ILT) | ||||
| Brief Summary | The researchers' specific aims are to test the following hypotheses: Hypothesis 1: A tumor can be completely ablated by ILT with MRI-guidance. Hypothesis 2: The MRI-based 3D temperature map of tissue during ILT is predictive of destruction. Hypothesis 3: The 3D "thermal dose" map that is based on the tissue's temperature over time is more predictive of tissue destruction than the temperature map. |
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| Detailed Description | The goal is to evaluate the use of minimally invasive interstitial laser therapy (ILT) in the brain. Our group is in a unique position to offer image-guided ILT because of our expertise and resources here at Brigham & Women's Hospital in the Departments of Neurosurgery and Radiology. The therapy will be monitored and controlled by the use of magnetic resonance imaging (MRI). ILT is a minimally invasive procedure in which the targeted tissue is thermally destroyed in situ in a controlled fashion. The intra-operative MRI provides a way to "see" the treatment. It can be used to treat disease by guiding surgery by providing images of tissue changes during therapy. In spite of its appeal as a minimally invasive technique, MRI-guided ILT is not commonly practiced in the United States. One reason is that proper clinical implementation of ILT requires an operating room (OR) setting and an MRI scanner - a very rare combination. Our MRI-OR suite includes a sterile procedure room with a 0.5 Tesla vertically "open" magnet. In the past, we have performed MRI-guided ILT procedures in 9 patients. While few in number, this is the most extensive U.S. experience in ILT in the brain. We have recently created a new image networking and display package for the visualization of 3D information during laser therapy. This provides a view of multiple image planes taken through the tissue volume around the fiber tip. Each patient will undergo ILT. The procedure will be performed under anesthesia as per standard procedures. The surgical placement of the laser fiber is a procedure identical to the well-developed and practiced technique of brain biopsy. A hole approximately 1 cm in diameter will be drilled in the skull through which the laser fiber will be placed under image guidance to confirm the actual progress during the advance of the fiber. We will deliver energy at a rate and distribution of 1-12 watts/cm for exposures less than 20 minutes. After the laser has been turned off, and the tissue cooled, MRI will show the region of ablation. As needed, the laser fiber will be moved/re-located to assure that the total target has been ablated. After the treatment is complete, the fiber is withdrawn, final images are acquired and the surgical site is closed and dressed. On the day after the procedure, the patient will undergo a 24 hour follow-up MRI exam. There will be post-operative care as with any neurosurgical patient. The following continuous variables will be measured in this study:
The following statistical hypothesis tests will be conducted. Statistical Hypothesis 1. A tumor can be completely ablated by ILT with MRI-guidance. We propose that the difference between the mean pre-op tumor volumes and the post-op ablated volumes (VO and V1, respectively) is zero. Residual tumor is defined as (V0-V1). This will be determined by calculating the mean of the values of the proportion of residual tumor, defined as (V0-V1)/ V0. Use of the proportion normalizes the data for different sized tumors. Statistical Hypothesis 2. The MRI-based 3-D temperature map of the tissue during ILT is predictive of destruction. We propose that the difference between the mean post-op ablated volumes and the intra-operative critical temperature volumes (VT and V1, respectively) is zero. This will be determined by calculating the mean of the values of the proportion of the difference between them, defined as (VT-V1)/VT. Statistical Hypothesis 3. The thermal dose map is predictive of tissue destruction. We propose that the difference between the mean post-op ablated volumes and the intra-operative critical dose volumes (VD and V1, respectively) is zero. This will be determined by calculating the mean of the values of the proportion of the difference between them, defined as (VD-V1 /VD). Also, data will be collected through Neurological Examinations and GOC Questionnaire. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Brain Tumor | ||||
| Intervention ICMJE | Device: Interstitial Laser Therapy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Estimated Completion Date | January 2010 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00207350 | ||||
| Responsible Party | Peter M. Black, MD, PhD, Brigham & Women's Hospital | ||||
| Study ID Numbers ICMJE | 2001-P-001794 | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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