What is the mechanism of action of this treatment?

Cognitive-Sparing Stereotactic Radiosurgery (SRS) is a form of targeted radiation therapy that delivers high doses of radiation precisely to cancerous tumors while minimizing exposure to surrounding healthy brain tissue. This precision reduces the risk of cognitive decline, a common side effect of traditional whole-brain radiation therapy. The mechanism of action involves using advanced imaging techniques to map the tumor and critical brain regions, allowing for focused radiation that spares cognitive functions. This approach is crucial for cancer patients as it aims to control tumor growth while preserving quality of life by maintaining cognitive abilities.

What side effects are associated with this type of intervention?

Common treatments for cancer, such as targeted radiation therapies like Cognitive-Sparing Stereotactic Radiosurgery (SRS), and systemic treatments like chemotherapy, have several known side effects. Targeted radiation therapies can lead to acute toxicities such as fatigue, alopecia (hair loss), scalp erythema (redness), headaches, and low-grade nausea. Long-term side effects may include neurocognitive decline, which these therapies aim to minimize. Chemotherapy can cause a range of side effects including nephrotoxicity (kidney damage), neurotoxicity (nerve damage), and ototoxicity (hearing loss). Both treatment types can significantly impact the patient's quality of life, necessitating careful management and supportive care.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer, including targeted radiation therapies like stereotactic radiosurgery (SRS) that aim to minimize cognitive side effects. For instance, whole brain radiation therapy (WBRT) combined with stereotactic radiosurgery (SRS) has been used to treat brain metastases, with efforts to reduce cognitive decline. Additionally, drugs like temozolomide have been used in conjunction with radiation therapy for brain tumors, aiming to improve outcomes while managing side effects. These treatments reflect a broader trend towards precision medicine in oncology, focusing on maximizing efficacy while minimizing adverse effects.

What other types of research exist?

Promising novel alternatives to Cognitive-Sparing Stereotactic Radiosurgery for cancer patients include: 1) Brachytherapy, which involves implanting radioactive sources directly into or near the tumor to deliver high doses of radiation while sparing surrounding brain tissue. 2) Laser Interstitial Thermal Therapy, a minimally invasive technique using laser energy to ablate tumor tissue. 3) Systemic therapies such as immunotherapy and targeted therapies, which have shown potential in controlling both systemic and intracranial disease, particularly in cancers like melanoma and certain subtypes of non-small cell lung cancer.

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Radiation Therapy

Image-Guided Radiosurgery for Brain Tumor (IG-SRS Trial)

Phase 2

Recruiting

Led By Jona Hattangadi-Gluth, MD

Research Sponsored by Jona Hattangadi-Gluth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-treatment), 3 months and 6 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging and precise radiation treatment to help adult patients with 1 to 3 brain metastases. It aims to protect important brain areas during treatment, preserving cognitive functions like memory and attention.

Who is the study for?

Adults over 18 with 1-3 small brain metastases from cancers like lung or breast, who can undergo MRI scans and have a life expectancy over 6 months. They must be able to perform daily activities with mild symptoms at most and participate in neurocognitive tests. Pregnant women, those unable to use contraception, or patients previously treated with whole brain radiation are excluded.

What is being tested?

The trial is testing a precise radiosurgery technique that aims to spare cognitive function while targeting brain tumors. It uses advanced imaging methods to protect critical brain areas during treatment and assesses the effectiveness through biomarkers of radiation response.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of stereotactic radiosurgery include headaches, swelling, fatigue, hair loss at the treatment site, nausea, and short-term memory issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-treatment), 3 months and 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-treatment), 3 months and 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-treatment), 3 months and 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Attention/Processing Speed from baseline to 3 months after SRS

Change in Executive Functioning from baseline to 3 months after SRS

Change in Language functioning from baseline to 3 months after SRS

+1 more

Secondary study objectives

Diagnostic Imaging

Longitudinal changes in imaging biomarker mean diffusivity (MD) from DTI imaging

Longitudinal changes in imaging biomarker volume from volumetric MR imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Image-guided cognitive sparing brain SRSExperimental Treatment1 Intervention

This is a single arm phase II study where enrolled subjects will receive intracranial SRS will performed identically to standard of care, except for implementing additional imaging techniques and software for additional regional avoidance for cognitive sparing (specifically sparing white matter and the bilateral hippocampus)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-Sparing Stereotactic Radiosurgery (SRS) is a form of targeted radiation therapy that delivers high doses of radiation precisely to cancerous tumors while minimizing exposure to surrounding healthy brain tissue. This precision reduces the risk of cognitive decline, a common side effect of traditional whole-brain radiation therapy. The mechanism of action involves using advanced imaging techniques to map the tumor and critical brain regions, allowing for focused radiation that spares cognitive functions. This approach is crucial for cancer patients as it aims to control tumor growth while preserving quality of life by maintaining cognitive abilities.