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

Phase 1

Completed

Conditions: Lung Cancer

Interventions: Device: CyPath

Registration Number: NCT00894127

Lead Sponsor: Biomoda Inc.

Brief Summary: 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.

Detailed Description: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyPath Assay of Deep-Lung Sputum Sample	CyPath	Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent \[ie, cancer\] cells (RFCs) from deep-lung sputum samples.

Primary Outcome Measures

Name	Time	Method
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.	March 2011	Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer. 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 Low dose CT scan or "high-risk" normals," and lung cancer confirmed by pathology or "cancer").

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Helen F. Graham Cancer Center, Christiana Care Health System
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Newark, Delaware, United States
Waterbury Pulmonary Research
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Waterbury, Connecticut, United States
Radiology Associates of Albuquerque
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Albuquerque, New Mexico, United States