Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

Lung Cancer Clinical Trial

Official title:

Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673283
• Other study ID #: Pro00008644
• Secondary ID: 2485-07-6R6
• Status: Completed
• Phase: Phase 0
• First received: May 4, 2008
• Last updated: July 31, 2014
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer in the Lungs
• Neoplasm Metastasis

Intervention

Device:
• bi-plane chest radiography
Bi-plane radiography of the thorax

Locations

Country	Name	City	State
United States	Duke University Medcal Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 [ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The technique is effective in diagnosing early lung tumors.		end of the study	No
Secondary	The relative performance of BCI with respect to chest radiography and CT for lung cancer detection.		end of the study	No