LITT + Radiation Therapy for Brain Tumor

Recruiting at 4 trial locations

Overseen By Mark Mishra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Cardiac diseases, Infratentorial tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating brain tumors called gliomas. Researchers combine two treatments: Laser Interstitial Thermal Therapy (LITT), which uses heat to target tumor cells, and Hypofractionated Radiation Therapy, which delivers larger doses of radiation over a shorter period. The goal is to evaluate the effectiveness of this combination for patients with newly diagnosed high-grade gliomas. Suitable candidates have a brain tumor identified by an MRI and can undergo the laser treatment. As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to innovative treatment options for gliomas.

Will 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.

What prior data suggests that this treatment regimen is safe for treating gliomas?

Research has shown that Laser Interstitial Thermal Therapy (LITT) is generally safe for treating brain tumors. Studies indicate that LITT can effectively target tumors with a high success rate, though some patients have experienced side effects such as brain swelling, temporary nerve issues, or bleeding in the head. These complications are important to consider but are not very common.

For Hypofractionated Radiation Therapy (HFRT), research suggests it is well-tolerated for brain tumors. This treatment involves delivering a higher dose of radiation in fewer sessions. Some studies have found it effective in reducing symptoms and controlling tumor growth. While it may not be suitable for all types of tumors, it has been considered safe for many patients.

Both treatments show promise, but like any medical treatment, they come with potential risks. Participants in clinical trials should weigh these risks against the potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Laser Interstitial Thermal Therapy (LITT) with hypofractionated radiation therapy for brain tumors because it offers a more targeted and potentially less invasive approach than traditional methods. Unlike conventional radiation therapy that often requires longer treatment durations, this approach uses LITT to precisely heat and destroy tumor tissue, followed by focused radiation delivered in fewer, higher-dose fractions. This combination not only aims to improve treatment precision but also may reduce side effects and recovery time, making it a promising option for patients with brain tumors.

What evidence suggests that LITT and Hypofractionated Radiation Therapy could be effective for treating gliomas?

Research has shown that Laser Interstitial Thermal Therapy (LITT) is a promising treatment for brain tumors. Studies have found that LITT can safely target deep, cancerous brain tumors and may help reduce patients' need for steroids. Some individuals with glioblastomas, a type of brain tumor, have lived longer with LITT, even up to 26 months.

Hypofractionated Radiation Therapy (HFRT) is also effective, particularly for glioblastomas. It involves shorter treatment sessions and has demonstrated good survival rates. Specifically, 71.3% of patients were alive a year after treatment. In this trial, participants will receive a combination of LITT followed by HFRT, offering hope for people with newly diagnosed gliomas and making these options worth considering. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 a woman who can have children and have a recent negative pregnancy test.

Patients must have signed an approved informed consent

Exclusion Criteria

My cancer has spread to the lower part of my brain or its lining.

I do not have serious heart problems or recent major heart events.

I cannot undergo surgery for a stereotactic biopsy or laser ablation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laser Interstitial Thermal Therapy (LITT)

Participants undergo Laser Interstitial Thermal Therapy as an alternative to surgical resection

1 week

Hypofractionated Radiation Therapy

Participants receive hypo-fractionated radiation therapy, 25Gy/10 fractions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• LITT

Trial Overview 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.

How Is the Trial Designed?

Group I: LITT with Hypofractionated RT Experimental Treatment 2 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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Keep Punching Foundation

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

Laser interstitial thermal therapy (LITT) effectively ablated glioblastoma tumors in a rat model, achieving near-complete tumor removal as confirmed by MRI and histopathological evaluations.

Real-time MRI monitoring during the LITT procedure allowed for precise visualization and control of the ablation area, enhancing the technique's potential for use in clinical settings for treating brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of laser interstitial thermal therapy for tumor ablation under MRI monitoring in a rat orthotopic model of glioblastoma. Nagaraja, TN., Bartlett, S., Farmer, KG., et al.[2022]

MR-guided laser interstitial thermal therapy (LITT) is a minimally invasive procedure that uses laser heat to precisely target and ablate brain tumors and epileptic foci, showing significant advancements in treatment over the past decade.

The first LITT system received FDA approval in 2007 and was CE-marked in 2018, with its first application in a patient with recurrent glioblastoma occurring in December 2020, highlighting its growing acceptance and use in neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MR-guided laser interstitial thermal therapy in the treatment of brain tumours and epilepsy]. Nielsen, SH., Rasmussen, R., Ziebell, M., et al.[2021]

The study found a high level of agreement among five physicians measuring tumor volumes using Brainlab software, with intraclass correlation coefficients (ICCs) of 0.92 for preoperative, 0.90 for intraoperative, and 0.89 for postoperative volumes, indicating reliable measurements across different observers.

The overall ICC of 0.72 suggests good consistency in volume measurements, which is important for ensuring accurate assessments in laser interstitial thermal therapy (LITT) for brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraclass Correlations of Measured Magnetic Resonance Imaging Volumes of Laser Interstitial Thermal Therapy-Treated High-Grade Gliomas. Noh, T., Griffith, B., Snyder, J., et al.[2020]

Hypofractionated radiation therapy (HFRT) effectively reduced the volume of brain metastases in patients, with a median volume decrease of 54.9% at one month and 83.3% at seven months post-treatment, indicating strong efficacy in managing limited metastatic brain disease.

The study, involving 124 patients with 233 lesions, showed low rates of local failure (4.3%) and radiation necrosis (3.9%), suggesting that HFRT is a safe option for patients who are not suitable for surgical resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric Response of Limited Brain Metastatic Disease to Focal Hypofractionated Radiation Therapy. Wijetunga, AR., Jayamanne, DT., Adams, J., et al.[2021]

Laser interstitial thermal therapy (LITT) is a safe and minimally invasive treatment for brain tumors, showing improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic disease compared to those with primary glial neoplasms.

In a study of 19 patients, median OS after LITT was 25 months for metastatic patients and 24 months for those with primary glial neoplasms, indicating that LITT can be an effective option for extending survival in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy (LITT) for intracranial lesions: a single-institutional series, outcomes, and review of the literature. Dabecco, R., Gigliotti, MJ., Mao, G., et al.[2022]

In a study involving 20 patients with recurrent malignant gliomas, hypofractionated stereotactic radiotherapy (H-SRT) demonstrated a low toxicity profile, with no grade 3 toxicities or reoperations required due to treatment-related complications.

The study found that higher total doses of H-SRT (30 Gy and 35 Gy) were associated with a significantly better response rate (79%) compared to lower doses, suggesting that dose escalation could enhance treatment efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. Hudes, RS., Corn, BW., Werner-Wasik, M., et al.[2022]

Magnetic resonance imaging-guided laser interstitial thermal therapy (LITT) is a minimally invasive technique that has become increasingly effective for ablating brain tumors, thanks to advancements in real-time thermal imaging and laser technology.

LITT allows for selective destruction of tumor tissue while preserving surrounding healthy tissue, making it a viable surgical option for patients with inoperable brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided laser interstitial thermal therapy in neuro-oncology: a review of its current clinical applications. Rahmathulla, G., Recinos, PF., Kamian, K., et al.[2014]

In a study of 46 patients treated with hypofractionated stereotactic radiotherapy (HFSRT) after surgical resection of brain metastases, the 1-year local control rate was 88%, indicating that this treatment is effective in preventing the return of cancer in the treated area.

HFSRT was well tolerated with no severe acute side effects, suggesting it is a safe option for patients; however, over half of the patients experienced cranial progression, highlighting the need for close monitoring after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HFSRT of the resection cavity in patients with brain metastases. Specht, HM., Kessel, KA., Oechsner, M., et al.[2018]

A meta-analysis of 24 studies involving 2,365 patients showed that combining hypofractionated radiation therapy (HFRT) with immune checkpoint inhibitors (ICIs) significantly improves overall survival rates and locoregional recurrence-free survival compared to HFRT alone.

The combination treatment did not result in increased toxicity, indicating that it is a safer option for patients with brain metastases while enhancing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy with versus without immune checkpoint inhibitors in patients with brain metastases: A meta-analysis. Yang, L., Liu, L., Wu, X., et al.[2020]

Laser interstitial thermal therapy (LITT) demonstrated effective local control in 81.8% of patients with metastatic brain tumors or radiation necrosis, based on a study of 23 patients with at least 6 months of follow-up.

The median survival for patients after LITT treatment was 16 months, indicating a promising outcome for those with previously treated metastatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Principles of Patient Selection for Laser Interstitial Thermal Therapy for Metastatic Brain Tumor Management: A Multisite Institutional Case Series. Riviere-Cazaux, C., Bhandarkar, AR., Rahman, M., et al.[2022]

MRI-guided Laser Interstitial Thermal Therapy (LITT) is a minimally invasive technique that allows neurosurgeons to effectively treat challenging metastatic brain tumors by using laser-generated heat to destroy abnormal tissue.

This study highlights the growing role of focal therapies like LITT in managing intracranial metastatic disease, showcasing its potential to improve treatment outcomes for patients with difficult-to-treat brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Intracranial Metastatic Disease With Laser Interstitial Thermal Therapy. Salehi, A., Kamath, AA., Leuthardt, EC., et al.[2020]

The study confirmed that hypofractionated conformal stereotactic radiotherapy (HCSRT) can accurately predict the absorbed dose for brain lesions, with measured doses within 2% of calculated doses for all targets studied.

Over 93% of the dose distribution measurements were within 3% and 2 mm of the planned doses, indicating high reliability in treatment delivery for arteriovenous malformations (AVMs) and other brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid ionization chamber calibrated gel dosimetry in conformal stereotactic radiotherapy of brain lesions. Björeland, A., Lindvall, P., Karlsson, A., et al.[2009]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33436285/

The efficacy of hypofractionated radiotherapy (HFRT) with ... The 12-month OS and 24-month OS rate of HFRT in GBM were 71.3% and 34.8%, while the 6-month PFS and 12-month rate were 74.0% and 40.8%. Compared to low-BED ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1278321825000964

Hypofractionated radiotherapy of central nervous system ... The use of hypofractionated radiotherapy for central nervous system tumours is expanding, particularly due to the increase in reirradiation situations.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982054/

exploring efficacy and safety - Part 1. Brain and head and neck Hypofractionation offers advantages such as shorter treatment times, improved compliance, and under specific conditions, particularly in tumors ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06740955

NCT06740955 | Hypofractionated Radiotherapy This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01017/full

Efficacy and Safety of Hypofractionated Radiotherapy for ... Conclusions: HRF is efficacious and safe for the treatment of GBM. In individuals aged >70 years, treatment with HRF is superior to CFR in terms of OS. The role ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5620204/

Are three weeks hypofractionated radiation therapy (HFRT) ... The patients outcome is still poor. In this study we evaluated hypofractionated radiation therapy (HFRT), instead of standard fractionated radiation therapy, ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836783

Modified Target Delineation and Moderately ... This randomized clinical trial of patients with high-grade glioma compares the efficacy and safety of multimodal magnetic resonance imaging ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214751922001372

Clinical outcomes of Hypofractionated stereotactic ... Treatment with HFSRT for larger brain metastases using a similar dose-fractionation schedule was deemed safe and effective in symptom relief and tumor control.