A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide

NCT05414123 | Terminated

• 1 other identifier: BIOC-046
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The FORESEE Study is a multi-center, prospective clinical trial enrolling patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose, or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide, is a Laboratory Developed Test (LDT ) that is used commercially at the Physician's discretion in Biocept's CLIA certified, CAP accredited laboratory. CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM. The goal of the FORESEE Study is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.

Conditions

Leptomeningeal Metastasis; Leptomeningeal Disease; Leptomeningeal Neoplasms; Breast Cancer; Non-Small Cell Lung Cancer

Keywords

Leptomeningeal Metastasis; Cerebro-Spinal Fluid; Liquid Biopsy; Tumor Cells

Outcome Measures

Primary Outcomes (1)

• Assess the impact of CNSide on treatment decisions

  The proportion of decision points during LM treatment in which the physician indicated that CNSide aided in their decision making.

  1 year

Secondary Outcomes (2)

• Evaluate CNSide as a treatment response monitoring device for LM tumors

  2 years

• The performance of CNSide of tumor cell detection in the CSF compared to cytology

  2 years

Study Arms (2)

Breast Cancer

Subjects with Breast Cancer of all subtypes and independent of Hormone status who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology

Device: CNSide

Non-Small Cell Lung Cancer

Subjects with Non-Small Cell Lung Cancer of all subtypes who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology

Device: CNSide

Interventions

CNSide DEVICE

The Cerebro-Spinal Fluid (CSF) of subjects enrolled into each cohort will be used for Standard of Care diagnostic assessments used for subjects with either confirmed or suspicious LM (Cytology, protein and glucose) in combination with CNSide analysis.

Breast Cancer; Non-Small Cell Lung Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be selected from all clinics where subjects having Breast Cancer or Non-Small Cell Lung Cancer having a suspicious or confirmed LM are being diagnosed or treated by Physicians.

You may qualify if:

• Subjects =\> 18 years of age
• All genders, races, or ethnic groups,
• Diagnosed with Breast Cancer or NSCLC who present with clinically suspected LM based on Investigator assessment of radiographic image, cytology, and clinical evaluation.
• Cytology positive and negative subjects will be included.
• Subjects willing to provide an Informed Consent.
• Subjects willing and able to undergo CSF or blood collection via Lumbar Puncture and Ommaya Reservoir as well as veni-puncture and shunt.
• Both patients with and without parenchymal brain metastases will be eligible as long as leptomeningeal metastases are suspected
• Subjects who previously had a diagnosis of Leptomeningeal Disease by Investigator assessment of radiographic image and clinical evaluation and cytology.

You may not qualify if:

• Subjects who do not have cancer,
• Subjects with other types of tumors than breast or lung cancer
• Subjects diagnosed with a primary brain tumor
• Subjects who are unable to undergo lumbar puncture, a shunt or veni-puncture.
• Lack of suspicious LM based in imaging or clinical evaluation.
• Ordering the Commercial CNSide test while subject is on study
• Pregnant women and adults lacking capacity to consent for themselves

Sponsors & Collaborators

• Biocept, Inc.: lead
• ICON plc: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235-1979, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis; Meningeal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Priya Kumthekar, MD

  Northwestern University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: September 7, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)