MRI-Guided LITT for Treatment Metastatic Brain Tumors

NCT01736722 | Withdrawn

• 1 other identifier: Pro00002569
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The Methodist Hospital Neurological Institute is conducting a clinical trial for patients suffering from Metastatic brain tumors. The objective for this study is to evaluate the safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance for the treatment of brain metastasis. Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. The tumor will then be heated by the laser and monitored by study physicians through the real-time MRI to see and control temperatures in the tissue. One in place, the thermal laser will then surgically remove the lesions. After the procedure, post treatment MR images will thenbe acquired for the determination of the effective treatment region.

Conditions

Brain Tumor

Keywords

Laser Induced Thermal Therapy; Metastatic cancer; Brain Tumor; Visualase; Treatment resistant; Magnetic Resonance Thermal Imaging; Magnetic Imaging

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility

  Safety: To determine that the procedure can be safely tolerated without adverse events based on day 30 procedure-related morbidity and mortality. Feasibility: To determine that the the rate of technical success or failure to complete the initial procedure with no associated major complications.

  30d

Secondary Outcomes (1)

• Number of patients with survival

  30 days

Study Arms (1)

MRI-guided laser induced thermal therapy

EXPERIMENTAL

The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.

Device: Visualase®

Interventions

Visualase® DEVICE

The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.

MRI-guided laser induced thermal therapy

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to conventional medical therapy.
• 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 radio- surgery, chemotherapy, and/or whole brain radiotherapy).
• Four 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 \>50.
• Patients age 19 and older.

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, some pacemakers or defibrillators, non- compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
• Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible with receiving gadolinium-DTPA.
• Based on Treatment Planning Imaging (MR and/or CT):
• Lesions localized in the brain stem.
• Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
• Presence of more than 4 brain tumors at the time of enrollment.
• Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
• Positive pregnancy test for women of child-bearing age.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Methodist Neurological Institute - Department of Neurosurgery

Houston, Texas, 77030, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pamela Z New, M.D.

  Methodist Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 29, 2012
• Study Start: January 22, 2009
• Primary Completion: March 5, 2014
• Study Completion: March 5, 2014
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)