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

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. Identifier: NCT00207350
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Alexandra J Golby, Brigham and Women's Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Brain Tumor Device: Interstitial Laser Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurosurgical Use of Interstitial Laser Therapy (ILT)
Study Start Date : January 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Brain tumor
Neurosurgical use of Interstitial Laser therapy
Device: Interstitial Laser Therapy
Other Name: ILT

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00207350

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United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02155
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Golby Alexandra, MD Brigham and Women's Hospital

Additional Information:
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.

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Responsible Party: Alexandra J Golby, Professor, Brigham and Women's Hospital Identifier: NCT00207350     History of Changes
Other Study ID Numbers: 2001-P-001794
First Posted: September 21, 2005    Key Record Dates
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:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases