Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Primary Objective:

• To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay using sputum specimens from two cohorts of participants and estimate the required sample size to finalize a protocol for a pivotal study.

Secondary Objectives:

• To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells demonstrating red fluorescence under a microscope with ultraviolet (UV) light being observed with a FITC (Fluorescein isothiocyanate) Filter.
• To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.

Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by reacting to the increased number of low-density lipoproteins coating the surface of cancer cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under specific wavelengths of light. The primary objective of this clinical trial was to determine the clinical sensitivity and specificity of the CyPath® Lung Cancer Detection Assay ("CyPath® Assay") using sputum specimens from two cohorts of Participants. The Study design included a protocol to assess the capability of the Biomoda CyPath® Lung Cancer Detection Assay to detect cancer in comparison with routine high-resolution, low-dose Computed Tomography (LDCT) scans.

Study results showed that the CyPath® Assay is a significant new biomarker for lung cancer with sensitivity at 77% and specificity at 58%, and an overall accuracy of 81.3% in the ability of the CyPath® assay and specific patient factors to correctly classify groups of Study participants into the cancer or high-risk cohorts. Testing for the Study was performed at multiple locations to assess the efficacy of the CyPath® Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the Study and assigned to one of two cohorts (smoker with clear LDCT scan or "high-risk normals," and lung cancer confirmed by pathology or "cancer").

Optimization of the Assay can lead to improved sensitivity and specificity. Increase in sample size and evaluation of the entire sputum sample can increase data collection and differentiation between cohorts. Technicians in the current Study examined 12 slides containing approximately 600,000 cells. The average sputum sample pellet translates to a potential of approximately 3.5 million cells for evaluation. Evaluating the full sputum sample with the CyPath® Assay can be accomplished through flow cytometry and would increase the capture and analysis of exfoliated cancer cells in the sample. In-house studies evaluated samples from five different cancer cell lines using flow cytometry. Preliminary results showed that cancer cell lines were detected with significant fluorescence apart from normal cell fluorescence. Refinements for using the flow cytometer include optimizing the liquid-based assay and sample analysis and focus on concentration, incubation time and optimal sample volume.

Inclusion Criteria:

• Male or female Veterans
• Study Participants must be willing to provide primary care physician contact information and agree to have medical information released if indicated
• Meet requirements of one of the two cohorts in the study:

• Cohort 1: Heavy Smoker

  • Defined as 20 pack years or greater (e.g., 1 pack/day for 20 years or 2 packs/day for 10 years).

• Cohort 2: Known Lung Cancer

  • Recently diagnosed with Stage I - IV lung cancer with either central (bronchogenic) or peripheral tumor location, and prior to surgery or other therapy for the cancer; Participants with a central or peripheral pulmonary recurrence of lung cancer following primary therapy may also be enrolled. Sputum samples for this cohort may be collected at or after a diagnostic bronchoscopy.

Exclusion Criteria:

• Severe obstructive lung disease
• Angina with minimal exertion
• Pregnancy
• Have or have had cancer other than lung cancer within one year
• Worked in the mining Industry

• Alquest
• Quintiles
• Radiology Associates of Albuquerque
• New Mexico Technical Institute of Mining and Technology
• Department of Veterans Services