Not Yet RecruitingPhase 2NCT07789912

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

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.

Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov

StatusNot Yet Recruiting
PhasePhase 2
U.S. locations1
SponsorUniversity of Miami
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Miami
Interventions being studied
Radiation: Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)
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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

Inclusion 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. Exclusion 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.

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Study sites

U.S. locations

  • University of MiamiMiami, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 27, 2026. Always confirm current availability with the study team.

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