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Neurosurgical Use of Interstitial Laser Therapy (ILT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Ferenc Jolesz, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00207350
First received: September 12, 2005
Last updated: August 14, 2013
Last verified: August 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurosurgical Use of Interstitial Laser Therapy (ILT)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ablation of lesion [ 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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Brain tumor
Neurosurgical use of Interstitial Laser therapy
Device: Interstitial Laser Therapy
Device
Other Name: ILT

  Show Detailed Description

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Joanne E. O'Hara, M.A. 617-732-6992 johara1@partners.org

Locations
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02155
Contact: Joanne OHara, MA       johara1@partners.org   
Principal Investigator: Ferenc Jolesz, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Ferenc Jolesz, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
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.

Responsible Party: Ferenc Jolesz, Chief, Radiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00207350     History of Changes
Other Study ID Numbers: 2001-P-001794
Study First Received: September 12, 2005
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Brain Tumor

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014