Back to results

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

Primary Purpose

Brain Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MRI-Guided Laser Induced Thermal Therapy

About this trial

This is an interventional treatment trial for Brain Neoplasms focused on measuring brain, metastasis, neoplasm, tumor, Patients with secondary brain neoplasms, laser therapy, laser interstitial thermal therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

North Shore University HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Accrual of patient survival post Visualase therapy

Procedure-related morbidity and mortality

Full Information

NCT ID

NCT00787982

First Posted

October 29, 2008

Last Updated

December 30, 2009

Sponsor

Visualase, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00787982

Brief Title

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

Official Title

Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2009 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Visualase, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment. The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). 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. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Neoplasms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

MRI-Guided Laser Induced Thermal Therapy

Intervention Description

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 Information:

Title

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

Time Frame

within 24 hours following the procedure

Secondary Outcome Measure Information:

Title

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

Time Frame

Immediately following treatment (day 0)

Title

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

Time Frame

from day 0 to patient release

Title

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

Time Frame

Day 30, 90, and 180 days post procedure

Title

Accrual of patient survival post Visualase therapy

Time Frame

Sooner of 3 years or patient death

Title

Procedure-related morbidity and mortality

Time Frame

30, 90,180 days post procedure

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela Kribs, R.N., BSN

Phone

516-562-3058

pkribs@NSHS.edu

Facility Information:

Facility Name

North Shore University Hospital

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

pamela kribs, R.N.,BSN

Phone

516-562-3058

pkribs@NSHS.edu

First Name & Middle Initial & Last Name & Degree

Michael Schulder, MD

12. IPD Sharing Statement

Links:

URL

http://www.visualaseinc.com

Description

Sponsors website

Learn more about this trial

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

We'll reach out to this number within 24 hrs