Neurosurgical Use of Interstitial Laser Therapy (ILT) - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00207350

Purpose

The researchers' specific aims are to test the following hypotheses:

Hypothesis 1: A tumor can be completely ablated by ILT with MRI-guidance.

Hypothesis 2: The MRI-based 3D temperature map of tissue during ILT is predictive of destruction.

Hypothesis 3: The 3D "thermal dose" map that is based on the tissue's temperature over time is more predictive of tissue destruction than the temperature map.

Condition	Intervention
Brain Tumor	Device: Interstitial Laser Therapy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Neurosurgical Use of Interstitial Laser Therapy (ILT)

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Ablation of tumor [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patients undergoing ILT will be assessed pre- and post-operatively based on a neurological exam by a physician and patient self-assessment using the Glioma Outcomes Questionnaire [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: Interstitial Laser Therapy Device

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female
Age 18+
Surgically difficult to access tumors including intracerebral metastases and vascular malformations

Exclusion Criteria:

Patients unwilling or unable to give written consent
Patients at risk for cardiac ischemia
Patients who cannot physically fit in the MRI scanner in the MRI OR
Patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel, and other internal ferromagnetic objects
Patients with coagulopathies, severe medical problems, cardiac arrhythmias or abnormal BUN

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207350

Locations

United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Peter M. Black, MD, PhD

Brigham and Women's Hospital

More Information

Additional Information:

Website for Image Guided Therapy Program at Brigham & Women's Hospital This link exits the ClinicalTrials.gov site

Publications:

Schulze PC, Vitzthum HE, Goldammer A, Schneider JP, Schober R. Laser-induced thermotherapy of neoplastic lesions in the brain--underlying tissue alterations, MRI-monitoring and clinical applicability. Acta Neurochir (Wien). 2004 Aug;146(8):803-12. Epub 2004 Jun 7. Review.

Peller M, Muacevic A, Reinl H, Sroka R, Abdel-Rahman S, Issels R, Reiser MF. [MRI-assisted thermometry for regional hyperthermia and interstitial laser thermotherapy] Radiologe. 2004 Apr;44(4):310-9. German.

McNichols RJ, Gowda A, Kangasniemi M, Bankson JA, Price RE, Hazle JD. MR thermometry-based feedback control of laser interstitial thermal therapy at 980 nm. Lasers Surg Med. 2004;34(1):48-55.

Leonardi MA, Lumenta CB. Stereotactic guided laser-induced interstitial thermotherapy (SLITT) in gliomas with intraoperative morphologic monitoring in an open MR: clinical expierence. Minim Invasive Neurosurg. 2002 Dec;45(4):201-7.

Kuroda K, Kettenbach J, Nabavi A, Silverman SG, Morrison PR, Jolesz FA. Clinical trials of MR thermography for laser ablation of brain tumors. Journal of the Japanese Society for Magnetic Resonance in Medicine (JMRM) 2002; 21;7,8:298-306.

Straube T, Kahn T. Thermal therapies in interventional MR imaging. Laser. Neuroimaging Clin N Am. 2001 Nov;11(4):749-57. Review.

Muacevic A, Peller M, Sroka R, Kalusche B, Pongratz T, Kreth FW, Steiger HJ, Reiser M, Reulen HJ. [Brain protective interstitial laser thermotherapy. Therapy of brain tumors without secondary damage] MMW Fortschr Med. 2001 May 28;143 Suppl 2:87-8. German.

Responsible Party:	Brigham & Women's Hospital ( Peter M. Black, MD, PhD )
Study ID Numbers:	2001-P-001794
Study First Received:	September 12, 2005
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00207350 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Brain Tumor

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009