Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Information source: Biomoda Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: CyPath (Device)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Biomoda Inc. Official(s) and/or principal investigator(s):
Constance Dorian, BS Biology, Study Director, Affiliation: Unaffiliated
Lara Patriquin, MD, Principal Investigator, Affiliation: Radiology Associates of Albuquerquqe
Thomas Bauer, MD, Principal Investigator, Affiliation: Helen F Graham Cancer Center, Christiana Care
Overall contact:
Constance Dorian, BS Biology, Phone: 505 350-6884, Email: cjdorian@gmail.com
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.
Clinical Details
Official title: Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Study design: Diagnostic, Non-Randomized, Single Blind (Investigator), Historical Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
- Worked in the mining Industry
Locations and Contacts
Constance Dorian, BS Biology, Phone: 505 350-6884, Email: cjdorian@gmail.com
Radiology Associates of Albuquerque, Albuquerque, New Mexico 87109, United States; Recruiting
Lara Patriquin, MD, Principal Investigator
Additional Information
Lung Cancer Alliance
Starting date: March 2009
Ending date: December 2009
Last updated: May 5, 2009
|
