Clinical trial · Interventional
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
Pilot Study Evaluating the Utility of OncoCEE (Cell Enrichment and Extraction) Technology, a Novel Immunocytochemical Microfluidic Device, in the Diagnosis of Leptomeningeal Metastasis (LM) From Breast Cancer Through Identification of Circulating Tumor Cells (CTCs) in Cerebrospinal Fluid (CSF)
- 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 study will prospectively enroll 36 evaluable subjects with breast cancer who are undergoing workup for clinical suspicion of leptomeningeal metastasis (LM). Neuroimaging consisting of MRI of the brain or total spine (or both, as clinically indicated) will be obtained in all patients. Patients will also undergo a lumbar puncture and standard CSF evaluation, which may consist of intracranial pressure measurement, CSF protein, glucose, white and red cell analysis, infectious cultures, as well as conventional cytopathologic analysis (cytocentrifuge). An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Leptomeningeal Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoCEE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OncoCEE
- description
- Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
- interventionNames
- Device: OncoCEE
Primary outcomes (2)
- measure
- Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
- timeFrame
- 6 months
- description
- Total number of participants with leptomeningeal metastasis detected (ER status)
- measure
- Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult (18 years or older) patients, with invasive breast cancer, of all racial and ethnic origins * Undergoing lumbar puncture for clinical or radiographic suspicion of leptomeningeal metastasis * Provide study-specific informed consent * Patients with unequivocal or suspicious MRI findings. * Of those with a definitive diagnosis of LM (i.e. positive CSF cytology), 10 evaluable patients will be accrued. Exclusion Criteria: * Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.
References
Publications (0)
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