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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jona Hattangadi-Gluth, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+