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ctDNA-Guided Intraventricular Therapy for CNS Malignancies

ConditionsLeptomeningeal DiseaseGlioblastomaBrain MetastasesNon-Small Cell Lung CancerBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAlireza Mansouri

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Diagnosis of histologically or cytologically confirmed HER2+ breast cancer, or triple negative breast cancer, or Stage IV non-small cell lung cancer, or recurrent high-grade glioma).

Undergoing clinically indicated cerebrospinal fluid (CSF) collection as part of routine clinical care: CSF may be obtained via lumbar puncture or existing CSF access device. Decision for CSF collection must be made independently by the treating clinical team and not solely for research purposes.

Detectable CSF ctDNA and/or positive CSF cytology, with consideration for CNS-directed management by the treating neuro-oncology team.

Disqualifiers

Age <18 years.

Inability to provide informed consent and no legally authorized representative (LAR) available.

Not undergoing clinically indicated CSF collection as part of standard clinical care.

Absence of detectable CSF ctDNA and absence of positive CSF cytology.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

77 Participants
are divided into 1 treatment group
Group A: ctDNA-Guided CNS ManagementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical central nervous system progression-free survival at 6 months (cCNS-PFS6)

Clinical CNS progression-free survival (cCNS-PFS6) will be assessed using the Neurologic Assessment in Neuro-Oncology Leptomeningeal Metastases (NANO-LM) scorecard. Disease progression will be determined by multidisciplinary adjudication based on neurologic assessment, radiographic findings, CSF cytology, and other relevant clinical information to distinguish leptomeningeal disease progression from alternative causes of neurologic deterioration.

Time frame
6 months

Secondary outcomes

1

Incidence of treatment-related neurologic and procedure-related adverse events

Frequency and severity of clinically significant neurologic toxicities, Ommaya reservoir-related complications, CNS-directed therapy-related complications, treatment-related hospitalizations, and other clinically relevant adverse events, graded according to CTCAE version 5.0 where applicable.

Time frame
From enrollment through 6 months
2

Change in cerebrospinal fluid circulating tumor DNA (CSF ctDNA) burden

Quantitative changes in CSF ctDNA variant allele frequency (VAF), including reduction or clearance of baseline VAF, and their association with clinical CNS progression-free survival. Exploratory analyses will evaluate whether a ≥50% reduction or complete clearance of baseline VAF is associated with durable clinical stability at 6 months.

Time frame
Baseline, Month 3, and Month 6

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alireza Mansouri

Lead sponsor

Milton S. Hershey Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: