MRI-Guided Laser Induced Thermal Therapy (LITT)

This study has been terminated.

(PI elected to close study)

Sponsor:

Collaborator:

Cancer Institute of New Jersey

Information provided by (Responsible Party):

University of Medicine and Dentistry New Jersey

ClinicalTrials.gov Identifier:

NCT01515085

First received: October 18, 2011

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2011

Last Updated Date

January 24, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01515085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

MRI-Guided Laser Induced Thermal Therapy

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with brain tumors receiving MR-guided laser ablation

Condition ^ICMJE

Malignant Glioma

Intervention ^ICMJE

Procedure: laser interstitial thermal therapy

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

Other Names:

laser ablation
LITT

Study Group/Cohort (s)

biopsy proven glioma, no prior treatment

Intervention: Procedure: laser interstitial thermal therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01515085

Other Study ID Numbers ^ICMJE

0220110114

Has Data Monitoring Committee

Responsible Party

University of Medicine and Dentistry New Jersey

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Cancer Institute of New Jersey

Investigators ^ICMJE

Principal Investigator:

Shabbar F Danish, MD

University of Medicine and Dentistry New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top