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

• ClinicalTrials.gov Identifier: NCT05414123
• Recruitment Status: Recruiting
• First Posted: June 10, 2022
• Last Update Posted: April 25, 2023
• Sponsor: Biocept, Inc.
• Collaborator: ICON plc
• Information provided by (Responsible Party): Biocept, Inc.

Tracking Information

• First Submitted Date: June 8, 2022
• First Posted Date: June 10, 2022
• Last Update Posted Date: April 25, 2023
• Actual Study Start Date: September 7, 2022
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2022)

Assess the impact of CNSide on treatment decisions [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 9, 2022)

• Evaluate CNSide as a treatment response monitoring device for LM tumors [ Time Frame: 2 years ]
  The correlation of changes in tumor cell number throughout treatment with clinical evaluation, cytology, and radiographic results.
• The performance of CNSide of tumor cell detection in the CSF compared to cytology [ Time Frame: 2 years ]
  The comparison of the sensitivity, specificity, PPV and NPV of CNSide to cytology in detection of tumor cells in the CSF (Cytology being the reference standard)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
• Official Title: A Longitudinal Therapy Response Monitoring Study in Subjects With Leptomeningeal Metastases Using CNSide (CSF Tumor Cells) Compared to Standard of Care (CSF Cytology, Clinical Evaluation, and Imaging).
• 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.
• Detailed Description: 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). LM is a devastating complication of breast cancer and NSCLC and is diagnosed via clinical evaluation, MRI (with and without contrast of the brain and spine), and CSF Cytology. These methods have limited sensitivity and specificity. Furthermore, they lack the ability to quantitatively measure the LM's response to treatment. These hindrances create challenges for physicians to manage LM or to determine the best course of treatment. CNSide, is a Laboratory Developed Test (LDT ) that is analytically validated and run commercially in Biocept's CLIA certified, CAP accredited laboratory at the Physician's discretion. CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM. Data derived from case studies suggest that the detection of tumor cells in the CSF by CNSide can be used by Physicians to monitor the response of the LM tumor to treatment and improve the ability to make treatment decisions in patients with LM. Subjects enrolled onto the trial will be treated per Standard of Care. The diagnostic tests used to either diagnose LM, or monitor the LMs response to treatment will be Standard of Care, in combination with CNSide. The goal of the FORESEE Study is to further evaluate the performance of CNSide for LM in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

Intervention

Device: CNSide

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.

Study Groups/Cohorts

• 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
  Intervention: 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
  Intervention: Device: CNSide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 9, 2022): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2025
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Barbara Blouw, PhD; 858-320-8200 ext 208; bblouw@biocept.com

Contact: David Isley, PhD; 858-223-0649 ext 374; disley@biocept.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05414123
• Other Study ID Numbers: BIOC-046
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is no plan to make the IDP available to other researchers.

• Current Responsible Party: Biocept, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Biocept, Inc.
• Original Study Sponsor: Same as current
• Collaborators: ICON plc

Investigators

• Principal Investigator: Priya Kumthekar, MD; Northwestern University Medical Center

• PRS Account: Biocept, Inc.
• Verification Date: April 2023