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

NCT ID: NCT00894127

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CyPath Assay of Deep-Lung Sputum Sample

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.

Group Type: EXPERIMENTAL

CyPath

Intervention Type: DEVICE

CyPath diagnostic assay for the early detection of lung cancer using sputum

Interventions

CyPath

CyPath diagnostic assay for the early detection of lung cancer using sputum

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alquest

INDUSTRY

Sponsor Role: collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Radiology Associates of Albuquerque

OTHER

Sponsor Role: collaborator

New Mexico Technical Institute of Mining and Technology

UNKNOWN

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Biomoda Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constance Dorian, BS Biology

Role: STUDY_DIRECTOR

Lara Patriquin, MD

Role: PRINCIPAL_INVESTIGATOR

Radiology Associates of Albuquerquqe

Thomas Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Helen F Graham Cancer Center, Christiana Care

Locations

Waterbury Pulmonary Research

Waterbury, Connecticut, United States

Helen F. Graham Cancer Center, Christiana Care Health System

Newark, Delaware, United States

Radiology Associates of Albuquerque

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

MODA-001

Identifier Type: -

Identifier Source: org_study_id