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MRI-Guided Laser Induced Thermal Therapy (LITT)

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ClinicalTrials.gov Identifier: NCT01515085
Recruitment Status : Terminated (PI elected to close study)
First Posted : January 23, 2012
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Malignant Glioma Procedure: laser interstitial thermal therapy

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 : Observational
Actual Enrollment : 1 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: three years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: three years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01515085     History of Changes
Other Study ID Numbers: 0220110114
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

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