MDACC Study Summary 2007-0610

Study Summary
No. 2007-0610:.......Brain......Jeffrey Weinberg......Neurosurgery

Study Summary Title



Study Summary Number:	2007-0610

Study 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

Physician

New Patient Referral



Name:	Jeffrey Weinberg	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neurosurgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2400 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	BioTex

Phase of Study:	N/A	Return Visit:	· 1 day: Physical/ neurologic exam, non-contrast CT scan · 1 week: Physical/ neurologic exam · 1 month: Physical/ neurologicexam + Imaging · 3 month: Physical/neurologic exam + Imaging · 6 month: Physical/ neurologic exam + Imaging

Treatment Agents:	PhoTex 15 Diode Laser Series 980 Visualase Cooled Laser Application System Visualase ENVISION Workstation	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Patient will be observed for 24 hours post-treatment in the inpatient setting.

Description/
Intervention:

The goal of this clinical research study is to learn about a new therapy device
called the Visualase® Thermal Therapy System (a device that uses a laser to
kill tumor cells and is guided using magnetic resonance thermal imaging
[MRTI]). The Visualase® Thermal Therapy System is used to treat metastatic
brain tumors. Researchers want to find out if it is possible to use this new
device in patients with metastatic brain tumor(s), each measuring 3 centimeters
(cm) or smaller. The safety of the device will also be studied.

Study Objectives / Outcomes

Investigate hypothesis that real-time, MR-guided laser induced thermal ablation of brain lesions under real-time thermal imaging guidance is both a feasible and safe minimally-invasive technique for local, highly conformal therapy of metastatic brain tumors.

Study Status Information



Study Activation / Registration Date:	07/09/2008

IRB Review and Approval Date:	07/09/2008

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient or family able and willing to give informed consent.

2) Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy). Failure is defined as local recurrence or failure of the previously treated lesion and will be determined by the treating surgeon based on a review of patient history and imaging.

3) Tumor size </= 3.0 cm in largest diameter.

4) MR imaging is not contraindicated for the patient

5) Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.

6) Able and willing to attend all study visits.

7) Karnofsky Performance Scale score >/=70 for patients over the age of 15.

8) Lansky Play Scale>/=70 for patients 15 years of age or younger.

Exclusion Criteria:

1) Patients or family unwilling or unable to give written consent.

2) Patients who cannot physically fit in, or are too heavy for, the BrainSUITE® MRI scanner

3) 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

4) Known sensitivity to gadolinium-DTPA

5) Based on Treatment Planning Imaging (MR and/or CT) done on the day of treatment: -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 or the posterior fossa. -Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves. -Evidence of recent (<2 weeks) hemorrhage.

6) Symptoms and signs of increased intracranial pressure

7) Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).

8) Patients who are unable to received corticosteroids.

9) Positive pregnancy test for women of child-bearing age.

Links

Registration Number: NCT00720837
Study Information on Clinical Trials Registry (clinicaltrials.gov)