Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948751
• Other study ID #: AAAQ4761
• Secondary ID: R03CA208547-01
• Status: Completed
• Start date: February 6, 2017
• Est. completion date: December 18, 2019

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Biocept, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)	Total number of participants with leptomeningeal metastasis detected (ER status)	6 months
Primary	Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)	Total number of participants with leptomeningeal metastasis detected (HER2 status)	6 months

External Links

•   Herbert Irving Comprehensive Cancer Center (HICCC) Clinical Trials Page