LITT + Radiation Therapy for Brain Tumor

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Maryland, Baltimore

Disqualifiers: Cardiac diseases, Infratentorial tumor, others

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.

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 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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 3 10 11 12}

Eligibility 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.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Hypofractionated Radiation Therapy (Radiation Therapy)
• LITT (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy (LITT) for intracranial lesions: a single-institutional series, outcomes, and review of the literature. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intraclass Correlations of Measured Magnetic Resonance Imaging Volumes of Laser Interstitial Thermal Therapy-Treated High-Grade Gliomas. [2020]

3. United States 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. [2022]

4. Austria pubmed.ncbi.nlm.nih.gov

Adaptation of laser interstitial thermal therapy for tumor ablation under MRI monitoring in a rat orthotopic model of glioblastoma. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Volumetric Response of Limited Brain Metastatic Disease to Focal Hypofractionated Radiation Therapy. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

HFSRT of the resection cavity in patients with brain metastases. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Liquid ionization chamber calibrated gel dosimetry in conformal stereotactic radiotherapy of brain lesions. [2009]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy with versus without immune checkpoint inhibitors in patients with brain metastases: A meta-analysis. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

[MR-guided laser interstitial thermal therapy in the treatment of brain tumours and epilepsy]. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Intracranial Metastatic Disease With Laser Interstitial Thermal Therapy. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

MRI-guided laser interstitial thermal therapy in neuro-oncology: a review of its current clinical applications. [2014]