Clinical trial · Interventional
MRI-Guided LITT for Treatment Metastatic Brain Tumors
Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI change and no enrollment ever, therefore no data available.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Visualase® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided laser induced thermal therapy
- description
- 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.
- interventionNames
- Device: Visualase®
Primary outcomes (1)
- measure
- Safety and Feasibility
- timeFrame
- 30d
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available