Image-Guided Radiosurgery for Brain Tumor

(IG-SRS Trial)

Overseen By Sheila Medina

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jona Hattangadi-Gluth

Disqualifiers: Pregnancy, Chemotherapy, Whole brain radiation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using radiosurgery, specifically Cognitive Sparing Brain Stereotactic Radiosurgery (SRS), to treat brain tumors while preserving memory and thinking skills. Researchers use advanced imaging techniques to protect critical brain areas while targeting tumors. This trial is for patients with up to three small brain tumors who can undergo MRI scans and maintain a good level of daily activity. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in brain tumor treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have planned chemotherapy on the day of the radiosurgery, you would not be eligible for the trial.

What prior data suggests that this image-guided cognitive sparing brain SRS is safe?

Research shows that stereotactic radiosurgery (SRS), tested in this trial, is generally well-tolerated by patients with brain tumors. Studies have found that SRS is safe and can lead to better cognitive outcomes. Patients often experience fewer issues with thinking and memory compared to treatments like whole-brain radiation therapy (WBRT). Additionally, survival rates with SRS are similar to those of other treatments without increased risks.

This trial focuses on protecting cognitive function during SRS by using advanced imaging to avoid critical brain areas. These methods aim to preserve thinking and memory while effectively treating the tumor. Overall, evidence suggests that SRS, especially with techniques to protect cognitive function, is a safe option for treating brain metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Sparing Brain Stereotactic Radiosurgery (SRS) because it uses advanced imaging techniques to precisely target brain tumors while minimizing damage to critical areas involved in cognition, like the white matter and bilateral hippocampus. Unlike traditional radiosurgery, which may impact cognitive functions due to less precise targeting, this method aims to preserve brain health and function by sparing essential cognitive regions. This innovative approach could lead to better quality of life outcomes for patients by reducing the potential cognitive side effects commonly associated with standard brain tumor treatments.

What evidence suggests that cognitive sparing brain SRS is effective for brain tumors?

Research shows that cognitive sparing brain stereotactic radiosurgery (SRS), which participants in this trial will receive, holds promise for treating brain tumors while protecting mental abilities. Studies indicate that SRS alone leads to less mental decline compared to whole-brain radiation therapy (WBRT), while still effectively controlling tumors. Recent data suggest that patients with up to 10 brain tumors have similar survival rates to those with fewer tumors when treated with SRS. Additionally, SRS has proven safe for patients with many brain tumors, demonstrating good results for mental function. Overall, these findings support SRS as an effective treatment for brain tumors, with the added benefit of better preserving mental abilities. ^{3 6 7 8 9}

Who Is on the Research Team?

Jona Hattangadi-Gluth, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness/Ability to undergo brain MRI scans

You have one to three small brain tumors, each less than 3 cm in size.

You are expected to live for at least 6 more months.

Exclusion Criteria

Pregnant or nursing women

Women of childbearing potential unwilling to use adequate contraception

You are not able to undergo a magnetic resonance imaging (MRI) scan with a contrast dye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo MRI with DTI and 3D volumetric imaging and a battery of neurocognitive tests

1 week

1 visit (in-person)

Treatment

Participants receive cognitive-sparing brain SRS with advanced imaging techniques

1 week

1 visit (in-person)

Follow-up

Participants are monitored for cognitive performance and imaging biomarkers at 1, 3, and 6 months post-treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Image-guided cognitive sparing brain SRS Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Jona Hattangadi-Gluth

Lead Sponsor

Trials

2

Recruited

310+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6200877/

Cognitive effects of stereotactic radiosurgery in adult patients ... In general, the results show little to no objective cognitive decline up to 4 months after SRS compared with WBRT. However, most trials suffered from ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049204/

Prognosis versus Actual Outcomes in Stereotactic ... Recent data increasingly show that survival after SRS as an initial treatment for up to 10 brain metastases is non-inferior compared to 2–4 BMs ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2536637

Effect of Radiosurgery Alone vs Radiosurgery With Whole ... The current trial found a higher rate of cognitive deterioration after WBRT than SRS alone despite improved intracranial tumor control ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109421001184

Outcomes in Patients With 4 to 10 Brain Metastases ... This study demonstrates that a dose-adapted SIMT SRS strategy including hypofractionation can be used to effectively and efficiently treat 4 to 10 brain ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00072-1/fulltext

Safety and Feasibility of Stereotactic Radiosurgery for ... We present here one of the largest studies evaluating SRS for patients with ≥15 BMs. SRS was safe, had favorable cognitive outcomes, and had comparable survival ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127210/

Safety and Feasibility of Stereotactic Radiosurgery for ... SRS was safe, had favorable cognitive outcomes, and had comparable survival outcomes to contemporary studies evaluating WBRT in this population. Treatment-naïve ...

7. redjournal.org redjournal.org/article/S0360-3016(23)05411-1/fulltext

Patient-Reported Cognitive Outcomes and Survival after ... We found that SRS was safe, had favorable cognitive outcomes, and comparable survival outcomes to contemporary studies evaluating WBRT in this patient ...

8. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00054-6/fulltext

Radiation Therapy for Brain Metastases: An ASTRO ... As WBRT offers no survival benefit over SRS and worse neurocognitive outcomes, SRS for patients with up to 4 intact brain metastases and ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/57/NCT04343157/Prot_000.pdf

1 Image-Guided Cognitive-Sparing Radiosurgery for Brain ... Data Safety and Monitoring ... impairment after fractionated stereotactic radiotherapy for benign or low-grade adult brain tumors.