Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2019-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Leptomeningeal Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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OncoCEE

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.

Group Type EXPERIMENTAL

OncoCEE

Intervention Type DEVICE

The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).

Interventions

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OncoCEE

The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).

Intervention Type DEVICE

Other Intervention Names

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OncoCEETM microchannel technology

Eligibility Criteria

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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.