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

NCT00894127 | Completed Phase 1 Results DMC

• 1 other identifier: MODA-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Porphyrin; Fluorescence; Diagnostic; Sputum Cytology; Early Detection

Outcome Measures

Primary Outcomes (1)

• 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.

  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").

  March 2011

Study Arms (1)

CyPath Assay of Deep-Lung Sputum Sample

EXPERIMENTAL

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.

Device: CyPath

Interventions

CyPath DEVICE

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

CyPath Assay of Deep-Lung Sputum Sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomoda Inc.: lead
• Alquest: collaborator
• Quintiles, Inc.: collaborator
• Radiology Associates of Albuquerque: collaborator
• New Mexico Technical Institute of Mining and Technology: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (3)

Waterbury Pulmonary Research

Waterbury, Connecticut, 06708, United States

Location

Helen F. Graham Cancer Center, Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Radiology Associates of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maria Zannes
• Organization: bioAffinity

mz@bioaffinitytech.com

505-400-9747

Study Officials

• Constance Dorian, BS Biology

  STUDY DIRECTOR

• Lara Patriquin, MD

  Radiology Associates of Albuquerquqe

  PRINCIPAL INVESTIGATOR

• Thomas Bauer, MD

  Helen F Graham Cancer Center, Christiana Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 30, 2019
• Results First Posted: September 22, 2014

Record last verified: 2019-10

Locations

US (3)