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


N/A
18 Years
N/A
Not Enrolling
Both
Malignant Glioma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression free survival

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Shabbar F Danish, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Institutional Review Board

Study ID:

0220110114

NCT ID:

NCT01515085

Start Date:

August 2011

Completion Date:

August 2014

Related Keywords:

  • Malignant Glioma
  • Glioma

Name

Location

Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903