RecruitingNot applicableNCT07789912
Official study title

BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies

Study summary

The purpose of this study is to determine the efficacy of BRain-AVOidant proton craniospinal irradiation (BRAVO pCSI) in adult participants with leptomeningeal metastases from solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRadiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Miami

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of Miami
Interventions being studied
Radiation: Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Participants with leptomeningeal metastases established radiographically and/or through Cerebrospinal Fluid (CSF) cytology or circulating tumor cells (CTCs). Participants may have newly diagnosed or recurrent LM. 2. Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2). 3. Participants with adequate bone marrow function. 4. Participants with a Karnofsky Performance Status (KPS) ≥ 60. 5. Male and female participants ages ≥ 18 years. 6. Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method. 7. Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.

Reasons someone may not be able to joinExclusion criteria

1. Participants with metastases within the memory-avoidance structures (hippocampus, corpus callosum, fornix, amygdala) that preclude developing a treatment plan that respects dosimetric constraints for these structures. 2. Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy. 3. Participants with extensive systemic disease and without reasonable systemic treatment options. 4. Participants unable to undergo MRI brain and spine with gadolinium contrast. 5. Participants who have had radiation therapy to the spinal cord with equivalent dose in 2Gy fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using α/β of 3. 6. Female participants who are pregnant or lactating. 7. Participants with impaired decision-making capacity.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of MiamiMiami, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.

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