Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

Completed

• Conditions: Breast Cancer; Leptomeningeal Metastasis
• Interventions: Device: OncoCEE

• Registration Number: NCT02948751
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2017-02-06
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Results First Submitted: 2021-08-25
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Results First Posted: 2024-06-06
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

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Exclusion Criteria

• Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OncoCEE	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)	6 months	Total number of participants with leptomeningeal metastasis detected (ER status)
Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)	6 months	Total number of participants with leptomeningeal metastasis detected (HER2 status)

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States