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NCT Number: NCT02948751

Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OncoCEE

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).

Other names: OncoCEETM microchannel technology

Primary outcomes

  1. Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)

    Time frame: 6 months

    Total number of participants with leptomeningeal metastasis detected (ER status)

  2. Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)

    Time frame: 6 months

    Total number of participants with leptomeningeal metastasis detected (HER2 status)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Biocept, Inc.
  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 28, 2016
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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