MRI-Guided Laser Induced Thermal Therapy (LITT)

This study has been terminated.
(PI elected to close study)
Sponsor:
Collaborator:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01515085
First received: October 18, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Malignant Glioma
Procedure: laser interstitial thermal therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
biopsy proven glioma, no prior treatment 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with brain tumors receiving MR-guided laser ablation

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01515085

Locations
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Shabbar F Danish, MD Rutgers, The State University of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01515085     History of Changes
Other Study ID Numbers: 0220110114
Study First Received: October 18, 2011
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 26, 2014