Clinical trial NCT02948751: Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Leptomeningeal Metastasis
Keywords: Breast Carcinoma
Breast tumors
Cancer of the Breast
Malignant tumor of the breast
breast cancer
leptomeningeal metastasis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Biocept, Inc.
First posted: 2016-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: Leptomeningeal metastasis (LM) is a condition in which cancer cells seed the meninges and may go on to invade the brain parenchyma, spinal cord, cranial nerves or peripheral nerves. It is a devastating complication of breast cancer, and is often considered in the differential diagnosis when patients with breast cancer present with new neurologic symptoms. It was previously thought to be a rare occurrence, but autopsy series have shown the true overall incidence to be up to 8%. In fact, while the incidence of meningeal metastasis from other malignancies has decreased, the opposite is true of breast cancer, in which clinical evidence suggests an increasing incidence.

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.

Primary outcomes:
measure: Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
timeFrame: 6 months
measure: Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References: