MRI-Guided Laser Induced Thermal Therapy

Malignant Glioma Clinical Trial

— LITT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01515085
• Other study ID #: 0220110114
• Status: Terminated
• Phase: N/A
• First received: October 18, 2011
• Last updated: May 20, 2014
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malignant Glioma

Intervention

Procedure:
• laser interstitial thermal therapy
residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		three years	No
Secondary	Overall survival		three years	No