ctDNA-Guided Intraventricular Therapy for CNS Malignancies

Conditions

• Brain Metastases
• Breast Cancer
• Glioblastoma
• Leptomeningeal Disease
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• CSF ctDNA-Guided Clinical Management — DEVICE
  Participants undergo clinically indicated cerebrospinal fluid (CSF) evaluation, including CSF cytology and the Belay Summit CSF circulating tumor DNA (ctDNA) assay. Results are incorporated into multidisciplinary neuro-oncology evaluation to inform CNS-directed clinical management. Treatment decisions, including intraventricular therapy, systemic therapy modification, radiation therapy, or other interventions, remain at the discretion of the treating physicians and are not mandated by the study protocol. The primary objective is to evaluate cCNS-PFS at 6 months. Secondary objectives include evaluating the safety of CNS-directed management and assessing the relationship between longitudinal CSF ctDNA dynamics and clinical outcomes.

Study Details

This prospective, single-center study will evaluate whether cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) testing using the Belay Summit assay can improve the clinical management of patients with malignant gliomas or brain metastases from non-small cell lung cancer (NSCLC) or breast cancer who are suspected of having central nervous system (CNS) disease. Patients undergoing clinically indicated CSF evaluation will receive standard clinical testing, including CSF cytology and the Belay Summit ctDNA assay. Treatment decisions will remain at the discretion of the treating multidisciplinary neuro-oncology team. The primary objective is to evaluate 6-month clinical CNS progression-free survival (cCNS-PFS), with secondary objectives assessing safety and the association between CSF ctDNA dynamics and clinical outcomes. Exploratory proteogenomic analyses will be performed on residual CSF specimens when sufficient sample is available.

Key Dates

First listed

Jul 8, 2026

Start date

Jan 1, 2027

Status verified

Jul 2026

Primary completion

Jul 1, 2030

Completion

Jan 1, 2032

Study Design

Enrollment

77 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ctDNA-Guided CNS Management
  Participants undergo clinically indicated cerebrospinal fluid (CSF) evaluation, including CSF cytology and the Belay Summit CSF circulating tumor DNA (ctDNA) assay. Clinical management is determined by the treating multidisciplinary neuro-oncology team based on the totality of clinical findings, including ctDNA results, imaging, CSF cytology, and neurologic assessment. Eligible participants are followed prospectively for clinical outcomes.

Primary Outcome Measure

Clinical central nervous system progression-free survival at 6 months (cCNS-PFS6) [ Time Frame: 6 months ]

Central Contacts

• Crystal Sowers
  7175315471
  [email protected]

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