Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

Columbia University

Status: Completed

Conditions: Breast Cancer; Leptomeningeal Metastasis

Treatments: Device: OncoCEE

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02948751

AAAQ4761

R03CA208547-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

OncoCEE

Experimental group

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.

Treatment:

Device: OncoCEE