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

NCT00894127 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2019-10-30

Study results available
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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.

Conditions

Interventions

DEVICE

CyPath

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

Sponsors & Collaborators

  • Alquest

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Radiology Associates of Albuquerque

    collaborator OTHER

  • New Mexico Technical Institute of Mining and Technology

    collaborator UNKNOWN

  • US Department of Veterans Affairs

    collaborator FED

  • Biomoda Inc.

    lead INDUSTRY

Principal Investigators

  • Constance Dorian, BS Biology

  • Lara Patriquin, MD · Radiology Associates of Albuquerquqe

  • Thomas Bauer, MD · Helen F Graham Cancer Center, Christiana Care

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894127 on ClinicalTrials.gov