Recruiting
Phase 1
Phase 2

MRI-Guided Laser Therapy

Sponsor:

Visualase, Inc.

Code:

NCT00787982

Conditions

Brain Neoplasms

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MRI-Guided Laser Induced Thermal Therapy

Study Details

Brief summary:

In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

Conditions

Brain Neoplasms

Study ID

NCT00787982

Start date

Sep, 2008

Status verified date

Dec, 2009

Completion date

Sep, 2010

Anticipated

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient or family able and willing to give informed consent.
  • Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).
  • Three or fewer previously treated or untreated lesion(s) in the brain.
  • Tumor size ≤ 3.0 cm in largest diameter.
  • MR imaging is not contraindicated for the patient.
  • Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
  • Able and willing to attend all study visits.
  • Karnofsky Performance Scale score >70 for patients over the age of 15.
  • Lansky Play Scale >70 for patients 15 years of age or younger.

Exclusion Criteria:

  • Patients or family unwilling or unable to give written consent.
  • Patients who cannot physically fit in, or are too heavy for, the MRI scanner.
  • Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
  • Known sensitivity to gadolinium-DTPA.
  • Based on Treatment Planning Imaging (MR and/or CT):

  • Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.
  • Lesions localized in the brain stem.
  • Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
  • Evidence of recent (<2 weeks) hemorrhage.
  • Presence of more than 3 brain tumors at the time of enrollment.
  • Symptoms and signs of increased intracranial pressure.
  • Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
  • Patients who are unable to receive corticosteroids.
  • Positive pregnancy test for women of child-bearing age.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

MRI-Guided Laser Induced Thermal Therapy

LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor

Primary outcome measure

  • Rate of technical success or failure to complete the initial procedure with no associated major complications. [ Time Frame: within 24 hours following the procedure ]

Central Contacts and Locations

Central contacts

Pamela Kribs, R.N., BSN

516-562-3058pkribs@NSHS.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

pamela kribs, R.N.,BSN

516-562-3058pkribs@NSHS.edu

Principal Investigator:

Michael Schulder, MD

More Information

Sponsor

Visualase, Inc.

Last update posted

Jan 1, 2010

Last verified

Dec, 2009

Keywords

  • brain
  • metastasis
  • neoplasm
  • tumor
  • Patients with secondary brain neoplasms
  • laser therapy
  • laser interstitial thermal therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Visualase, Inc. on 2010-01-01.