LITT + Radiation Therapy for Brain Tumor
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.
How is the LITT + Radiation Therapy treatment for brain tumors different from other treatments?
LITT (Laser Interstitial Thermal Therapy) is unique because it is a minimally invasive procedure that uses heat from a laser to destroy brain tumors while being guided by real-time MRI, allowing precise targeting and sparing surrounding healthy tissue. This approach is particularly useful for tumors in hard-to-reach areas where traditional surgery might be challenging.
358912What data supports the effectiveness of the treatment LITT + Radiation Therapy for Brain Tumor?
Research shows that Laser Interstitial Thermal Therapy (LITT) is effective for treating brain tumors, including primary tumors and metastases, by using heat to destroy tumor cells. Additionally, Hypofractionated Radiation Therapy (HFRT) has been shown to significantly reduce the size of brain metastases, with a high percentage of patients experiencing a reduction in tumor volume.
69101112Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is LITT combined with radiation therapy generally safe for treating brain tumors?
Research on hypofractionated radiation therapy (HFRT) for brain metastases shows it can be effective while minimizing toxicity, with low rates of radiation necrosis (tissue damage from radiation). Safety data from studies on similar treatments suggest that these therapies are generally safe for brain conditions, though specific safety data for LITT combined with radiation therapy is limited.
124711Eligibility Criteria
This trial is for adults over 18 with newly diagnosed gliomas, a type of brain tumor. They must be able to undergo MRI scans and have a Karnofsky performance status of at least 50%, indicating they can care for themselves. Women who can become pregnant must test negative for pregnancy and use effective contraception during the study.Inclusion Criteria
I've had a full physical and neurological exam in the last 30 days.
I am 18 years old or older.
My scans suggest I have a high-grade brain tumor.
I can do most of my daily activities by myself.
Exclusion Criteria
My cancer has spread to the lower part of my brain or its lining.
I cannot undergo surgery for a stereotactic biopsy or laser ablation.
Participant Groups
The trial tests a treatment regimen combining Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy on patients with new gliomas. LITT uses lasers to destroy tumor cells, followed by targeted radiation therapy in fewer high-dose sessions.
1Treatment groups
Experimental Treatment
Group I: LITT with Hypofractionated RTExperimental Treatment2 Interventions
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.
Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Central Maryland Radiation OncologyColumbia, MD
University of Maryland Greenebaum Cancer CenterBaltimore, MD
Maryland Proton Treatment CenterBaltimore, MD
UCH Kaufman Cancer CenterBel Air, MD
More Trial Locations
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
Keep Punching FoundationCollaborator
References
A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. [2022]A phase I dose escalation of hypofractionated stereotactic radiotherapy (H-SRT) in recurrent or persistent malignant gliomas as a means of increasing the biologically effective dose and decreasing the high rate of reoperation due to toxicity associated with single-fraction stereotactic radiosurgery (SRS) and brachytherapy.
Liquid ionization chamber calibrated gel dosimetry in conformal stereotactic radiotherapy of brain lesions. [2009]Hypofractionated conformal stereotactic radiotherapy (HCSRT) is an established method of treating brain lesions such as arteriovenous malformations (AVMs) and brain metastases. The aim of this study was to investigate the reliability of treatment plans in the terms of dose distribution and absorbed dose for HCSRT.
MRI-guided laser interstitial thermal therapy in neuro-oncology: a review of its current clinical applications. [2014]Magnetic resonance imaging-guided laser interstitial thermal therapy (LITT) is a minimally invasive treatment modality with recent increasing use to ablate brain tumors. When originally introduced in the late 1980s, the inability to precisely monitor and control the thermal ablation limited the adoption of LITT in neuro-oncology. Popularized as a means of destroying malignant hepatic and renal metastatic lesions percutaneously, its selective thermal tumor destruction and preservation of adjacent normal tissues have since been optimized for use in neuro-oncology. The progress made in real-time thermal imaging with MRI, laser probe design, and computer algorithms predictive of tissue kill has led to the resurgence of interest in LITT as a means to ablate brain tumors. Current LITT systems offer a surgical option for some inoperable brain tumors. We discuss the origins, principles, current indications, and future directions of MRI-guided LITT in neuro-oncology.
HFSRT of the resection cavity in patients with brain metastases. [2018]Aim of this single center, retrospective study was to assess the efficacy and safety of linear accelerator-based hypofractionated stereotactic radiotherapy (HFSRT) to the resection cavity of brain metastases after surgical resection. Local control (LC), locoregional control (LRC = new brain metastases outside of the treatment volume), overall survival (OS) as well as acute and late toxicity were evaluated.
Management of Intracranial Metastatic Disease With Laser Interstitial Thermal Therapy. [2020]Treatment approaches for metastatic brain tumors continue to evolve, with increasing recent emphasis on focal therapies whenever possible. MRI-guided Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical option that has broadened the capability of the neurosurgeon in treating difficult-to-treat intracranial lesions. This technology uses image-guided delivery of laser to the target lesion to generate heat and thereby ablate pathological tissue and has expanded the neurosurgical armamentarium for surgical treatment of brain metastases. In this study, we describe the indications for LITT in the management of intracranial metastatic disease and report our institutional experience with LITT.
Intraclass Correlations of Measured Magnetic Resonance Imaging Volumes of Laser Interstitial Thermal Therapy-Treated High-Grade Gliomas. [2020]Laser interstitial thermal therapy (LITT) is a minimally invasive therapeutic option for the treatment of brain tumors. Previous studies have quantitatively followed the ablated volumes of high-grade gliomas. Reported treatment volumes range from 28% to 100%, with no reported interobserver analysis. Because these volumes are subjectively measured, it is necessary to establish concordance between clinicians.
Hypofractionated radiation therapy with versus without immune checkpoint inhibitors in patients with brain metastases: A meta-analysis. [2020]The efficacy and safety of hypofractionated radiation therapy (HFRT) combined with immune checkpoint inhibitors (ICIs) in patients with brain metastases (BM) remain controversial. This meta-analysis was performed to compare the efficacy and safety of HFRT with and without ICIs in BM patients.
[MR-guided laser interstitial thermal therapy in the treatment of brain tumours and epilepsy]. [2021]MR-guided laser interstitial thermal therapy (LITT) is a minimally invasive neurosurgical procedure, which in the last decade has gained significant momentum of the treatment of intracranial tumours and epileptic foci. In brief, LITT utilises the heat from a stereotactically placed laser catheter to selectively ablate a lesion or a structure under real-time MRI guidance, which is summarised and discussed in this review. The first LITT system gained FDA approval in 2007 and was CE-marked in 2018. In December 2020, the first patient with recurrent glioblastoma was treated at the Department of Neurosurgery at Rigshospitalet, Copenhagen.
Laser interstitial thermal therapy (LITT) for intracranial lesions: a single-institutional series, outcomes, and review of the literature. [2022]Laser interstitial thermal therapy (LITT) is a minimally invasive treatment method in managing primary brain neoplasms, brain metastases, radiation necrosis, and epileptogenic lesions, many of which are located in operative corridors that would be difficult to address. Although the use of lasers is not a new concept in neurosurgery, advances in technology have enabled surgeons to perform laser treatment with the aid of real-time MRI thermography as a guide. In this report, we present our institutional series and outcomes of patients treated with LITT.
Adaptation of laser interstitial thermal therapy for tumor ablation under MRI monitoring in a rat orthotopic model of glioblastoma. [2022]Laser interstitial thermal therapy (LITT) under magnetic resonance imaging (MRI) monitoring is being increasingly used in cytoreductive surgery of recurrent brain tumors and tumors located in eloquent brain areas. The objective of this study was to adapt this technique to an animal glioma model.
Volumetric Response of Limited Brain Metastatic Disease to Focal Hypofractionated Radiation Therapy. [2021]Background: This is a retrospective study aimed at assessing the volumetric response, morbidity and failure rates of hypofractionated radiation therapy (HFRT) for definitive focal management of limited brain metastasis. Methods: Patients managed with HFRT for unresected limited metastatic (≤10 lesions) brain disease were entered into an ethics-approved database. Included patients had been deemed unsuitable for surgical resection, and lesions managed with prior radiation therapy were excluded. HFRT was delivered using IMRT or VMAT with 25 Gy or 30 Gy in five fractions. Individual lesions had volumetric assessment performed at three timepoints. The primary endpoint was the change of volume from baseline (GTV0) to one month post-HFRT (GTV1) and to seven months post-HFRT (GTV7). Secondary endpoints were local failure, survival and rates of radiation necrosis. Results: One hundred and twenty-four patients with 233 lesions were managed with HFRT. Median follow-up was 23.5 months with 32 (25.8%) patients alive at censure. Median overall survival was 7.3 months with 36.3% survival at 12 months. Superior survival was predicted by smaller GTV0 (p = 0.003) and increased percentage of volumetric response (p < 0.001). Systemic therapy was delivered to 81.5% of patients. At one month post-HFRT, 206 metastases (88.4%) were available for assessment and at seven months post-HFRT, 118 metastases (50.6%) were available. Median metastasis volume at GTV0 was 1.6 cm3 (range: 0.1-19.1). At GTV1 and GTV7, this reduced to 0.7 cm3 (p < 0.001) and 0.3 cm3 (p < 0.001), respectively, correlating to percentage reductions of 54.9% and 83.3%. No significant predictors of volumetric response following HFRT were identified. Local failure was identified in 4.3% of lesions and radiation necrosis in 3.9%. Conclusion: HFRT is an effective therapy for limited metastatic disease in the brain to maximise initial volumetric response whilst minimising toxicity.
Outcomes and Principles of Patient Selection for Laser Interstitial Thermal Therapy for Metastatic Brain Tumor Management: A Multisite Institutional Case Series. [2022]Laser interstitial thermal therapy (LITT) is an emerging treatment modality for both primary brain tumors and metastases. We report initial outcomes after LITT for metastatic brain tumors across 3 sites at our institution and discuss potential strategies for optimal patient selection and outcomes.