N/A
N=14
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
Breast Cancer · Leptomeningeal Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT02948751 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status) — 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OncoCEE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status) |
3; 1 | — |
| PRIMARY Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status) |
0; 1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02948751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.