Clinical trial · Interventional
ctDNA-Guided Intraventricular Therapy for CNS Malignancies
ctDNA-Guided Intraventricular Therapy Trial: A Prospective Study in Patients With Malignant Gliomas or Brain Metastases From Non-Small Cell Lung Cancer and Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Leptomeningeal Disease | Leptomeningeal Neoplasm | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSF ctDNA-Guided Clinical Management | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ctDNA-Guided CNS Management
- description
- 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.
- interventionNames
- Device: CSF ctDNA-Guided Clinical Management
Primary outcomes (1)
- measure
- Clinical central nervous system progression-free survival at 6 months (cCNS-PFS6)
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Ability to provide informed consent, or availability of a legally authorized representative (LAR). Exclusion Criteria: * 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. * Not being considered for CNS-directed management by the treating neuro-oncology team. * Clinical contraindications to CSF collection, including but not limited to: Significant intracranial mass effect; (e.g., midline shift \>5 mm or effacement of basal cisterns); Obstructive hydrocephalus or posterior fossa mass effect; Coagulopathy or bleeding risk precluding lumbar puncture or CSF access; Inability to safely obtain CSF access.
References
Publications (0)
Data not yet available