Lung Cancer Clinical Trial; Early Detection of Lung Cancer Via bi-Plane Correlation Chest Imaging

Early Detection of Lung Cancer Via bi-Plane Correlation Chest Imaging
This study is currently recruiting participants.
Verified by Duke University, May 2008
Sponsored by: Duke University

Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00673283

Purpose
This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired within a short time interval from slightly different posterior projections. The image data are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules present in the thoracic cavity are detected by examining the geometrical correlation of the detected signals in the two views. The data are alos viewed stereoscopically for visual diagnosis. The expected high sensitivity/specificity of the method has the potential to change the current state of practice, perhaps leading to a preventive lung cancer screening program for high-risk populations, similar to the mammography screening program currently in place for breast cancer.

Condition Intervention Phase
Lung Cancer
Metastatic Cancer in the Lungs
Device: bi-plane chest radiography
Phase 0

MedlinePlus related topics: Cancer Lung Cancer X-Rays
Drug Information available for: X-Rays
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment
Official Title: Early Detection of Lung Cancer Via bi-Plane Correlation Chest Imaging

Further study details as provided by Duke University:

Primary Outcome Measures:
The technique is effective in diagnosing early lung tumors. [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
The relative performance of BCI with respect to chest radiography and CT for lung cancer detection. [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental Device: bi-plane chest radiography
Bi-plane radiography of the thorax

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Criteria
Inclusion Criteria:

Normal individuals
Individuals with CT-confirmed subtle lung nodules.
Exclusion Criteria:

Individuals with acute pulmonary abnormalities or those in poor health conditions will be excluded due to the potential impact on the results as well as difficulty of acquiring the images. Pregnant women will also be excluded to avoid the exposure of the fetus to radiation.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673283

Contacts
Contact: Page Samei, PhD 919-684-7852 SAMEI@DUKE.EDU
Contact: H P McAdams, MD 919-684-7810 mcada003@mc.duke.edu

Locations
United States, North Carolina
Duke University Medcal Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Ehsan Samei, PhD 919-684-7852 samei@duke.edu
Contact: H P McAdams 919-684-7810 mcada003@mc.duke.edu
Principal Investigator: Ehsan Samei, PhD
Sub-Investigator: H P McAdams, MD
Sub-Investigator: Lacey Washington, MD
Sub-Investigator: David Delong, PhD

Sponsors and Collaborators
Duke University
More Information

Publications of Results:
Samei E, Stebbins SA, Dobbins JT 3rd, McAdams HP, Lo JY. Multiprojection correlation imaging for improved detection of pulmonary nodules. AJR Am J Roentgenol. 2007 May;188(5):1239-45. Erratum in: AJR Am J Roentgenol. 2007 Sep;189(3):512. McAdams, H Page [added].

Responsible Party: Duke University Medical Center ( Ehsan Samei )
Study ID Numbers: 2485-07-6R6
Study First Received: May 4, 2008
Last Updated: May 4, 2008
ClinicalTrials.gov Identifier: NCT00673283 [history]
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
lung cancer
nodules
radiography
CT
Stereoscopy

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Neoplasms

ClinicalTrials.gov processed this record on February 10, 2009

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