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Neurosurgical Use of Interstitial Laser Therapy (ILT) (ILT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207350
First Posted: September 21, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexandra J Golby, Brigham and Women's Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Alexandra J Golby, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Ablation of lesion [ Time Frame: During procedure ]

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 ]

Enrollment: 6
Study Start Date: January 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00207350


Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02155
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Golby Alexandra, 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: Alexandra J Golby, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00207350     History of Changes
Other Study ID Numbers: 2001-P-001794
First Submitted: September 12, 2005
First Posted: September 21, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Alexandra J Golby, Brigham and Women's Hospital:
Brain Tumor

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