Clinical trial NCT00894127: Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Official title: Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Lung Cancer
Porphyrin
Fluorescence
Diagnostic
Sputum Cytology
Early Detection
Lead sponsor: Biomoda Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alquest
name: Quintiles, Inc.
name: Radiology Associates of Albuquerque
name: New Mexico Technical Institute of Mining and Technology
name: US Department of Veterans Affairs
First posted: 2009-05-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: March 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: Waterbury Pulmonary Research
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center, Christiana Care Health System
state: Delaware
city: Albuquerque
country: United States
facility: Radiology Associates of Albuquerque
state: New Mexico
Study officials:
name: Constance Dorian, BS Biology
role: STUDY_DIRECTOR
affiliation: Radiology Associates of Albuquerquqe
name: Lara Patriquin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helen F Graham Cancer Center, Christiana Care
name: Thomas Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: