MRI-Guided LITT for Treatment Metastatic Brain Tumors
| Status: | Withdrawn |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 75 |
| Updated: | 1/19/2018 |
| Start Date: | January 22, 2009 |
| End Date: | March 5, 2014 |
Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors
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.
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.
This is a study for evaluating the feasibility and safety of MR-guided laser thermal ablation
of treatment-resistant brain tumors using the Visualase® Thermal Therapy System (Manufactured
by BioTex, Inc., Houston, TX). The Visualase system is FDA cleared for soft tissue ablation
in a number of surgical specialties including Neurosurgery (see appendix for documentation).
Patients with intracranial brain tumors measuring 3 cm or smaller in largest diameter that
have failed any conventional therapy (surgery, stereotactic radiosurgery and/or whole brain
radiotherapy) are eligible.
The target tissue containing the tumor will undergo MRI-guided laser induced thermal therapy.
MR imaging is used to define the treatment volume as well as plan and verify placement of the
applicator. The extent of ablation is quantitatively monitored and displayed during delivery
using real-time, MR temperature imaging. MR temperature imaging will also be used to monitor
and control the temperature of adjacent tissues. Treatment will be automatically stopped if
the MR temperature feedback system reports the temperature in the adjacent tissue has risen
above a preset threshold. Treatment can be manually stopped by the neurosurgeon monitoring
the treatment in real-time at any point during the procedure by simply turning off the power
to the laser from the Visualase® system console. After laser delivery, MR images can be used
to verify the extent of treatment and plan a therapy delivery if necessary.
of treatment-resistant brain tumors using the Visualase® Thermal Therapy System (Manufactured
by BioTex, Inc., Houston, TX). The Visualase system is FDA cleared for soft tissue ablation
in a number of surgical specialties including Neurosurgery (see appendix for documentation).
Patients with intracranial brain tumors measuring 3 cm or smaller in largest diameter that
have failed any conventional therapy (surgery, stereotactic radiosurgery and/or whole brain
radiotherapy) are eligible.
The target tissue containing the tumor will undergo MRI-guided laser induced thermal therapy.
MR imaging is used to define the treatment volume as well as plan and verify placement of the
applicator. The extent of ablation is quantitatively monitored and displayed during delivery
using real-time, MR temperature imaging. MR temperature imaging will also be used to monitor
and control the temperature of adjacent tissues. Treatment will be automatically stopped if
the MR temperature feedback system reports the temperature in the adjacent tissue has risen
above a preset threshold. Treatment can be manually stopped by the neurosurgeon monitoring
the treatment in real-time at any point during the procedure by simply turning off the power
to the laser from the Visualase® system console. After laser delivery, MR images can be used
to verify the extent of treatment and plan a therapy delivery if necessary.
Inclusion Criteria:
1. High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to
conventional medical therapy.
2. Patient or family able and willing to give informed consent.
3. 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).
4. Four or fewer previously treated or untreated lesion(s) in the brain.
5. Tumor size ≤ 3.0 cm in largest diameter.
6. MR imaging is not contraindicated for the patient.
7. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined
by the treating surgeon.
8. Able and willing to attend all study visits.
9. Karnofsky Performance Scale score >50.
10. Patients age 19 and older.
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 MRI scanner.
3. 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.
4. Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible
with receiving gadolinium-DTPA.
5. 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.
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