MRI-Guided Laser Induced Thermal Therapy

Terminated

• Conditions: Malignant Glioma
• Interventions: Procedure: laser interstitial thermal therapy

• Registration Number: NCT01515085
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biopsy proven glioma, no prior treatment	laser interstitial thermal therapy	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	three years

Secondary Outcome Measures

Name	Time	Method
Overall survival	three years

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States