Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

NCT00787982 | Unknown Phase 1 DMC

• 1 other identifier: VIS-BR-08-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of technical success or failure to complete the initial procedure with no associated major complications.

  within 24 hours following the procedure

Secondary Outcomes (5)

• Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments.

  Immediately following treatment (day 0)

• Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure

  from day 0 to patient release

• Local control of treated lesions as defined by volume of lesions increasing by no more than 25%

  Day 30, 90, and 180 days post procedure

• Accrual of patient survival post Visualase therapy

  Sooner of 3 years or patient death

• Procedure-related morbidity and mortality

  30, 90,180 days post procedure

Interventions

MRI-Guided Laser Induced Thermal Therapy DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visualase, Inc.: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Related Links

• Sponsors website

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pamela Kribs, R.N., BSN

CONTACT

516-562-3058; pkribs@NSHS.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: November 10, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

US (1)