MRI-Guided Laser Induced Thermal Therapy

Study Overview
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Brief Summary
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Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.

Detailed Description
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Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible. In this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures.

Official Title
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MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation

Conditions
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Malignant Glioma

Intervention / Treatment
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* Procedure: laser interstitial thermal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that have/will undergo MRgLITT for inoperable brain tumor. Tumor size < 3cm in transverse diameter for each planned applicator placement. Tumor size < 4 cm in largest dimension. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon. Karnofsky Performance Scale score > 70. ECOG performance status of 2 or better. Biopsy proven histologic diagnosis of malignant glioma. Exclusion Criteria: Patients with co-existing medical conditions with life expectancy < 1 year. Patients having received pre-ablation chemotherapy and/or radiation to lesion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| biopsy proven glioma, no prior treatment<br> | Procedure: laser interstitial thermal therapy<br>* residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy<br>* Other names: LITT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | three years |