MRI-Guided Laser Induced Thermal Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

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.

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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.

Conditions

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Malignant Glioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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biopsy proven glioma, no prior treatment

laser interstitial thermal therapy

Intervention Type PROCEDURE

residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy

Interventions

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laser interstitial thermal therapy

residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy

Intervention Type PROCEDURE

Other Intervention Names

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laser ablation LITT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No