Back to resultsEarly Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
Primary Purpose
Lung Cancer, Metastatic Cancer in the Lungs
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
bi-plane chest radiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, nodules, radiography, CT, Stereoscopy
Eligibility 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.
Sites / Locations
- Duke University Medcal Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
The technique is effective in diagnosing early lung tumors.
Secondary Outcome Measures
The relative performance of BCI with respect to chest radiography and CT for lung cancer detection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00673283
Brief Title
Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
Official Title
Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer in the Lungs
Keywords
lung cancer, nodules, radiography, CT, Stereoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
bi-plane chest radiography
Intervention Description
Bi-plane radiography of the thorax
Primary Outcome Measure Information:
Title
The technique is effective in diagnosing early lung tumors.
Time Frame
end of the study
Secondary Outcome Measure Information:
Title
The relative performance of BCI with respect to chest radiography and CT for lung cancer detection.
Time Frame
end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehsan Samei, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medcal Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17449766
Citation
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. doi: 10.2214/AJR.06.0843. Erratum In: AJR Am J Roentgenol. 2007 Sep;189(3):512. McAdams, H Page [added].
Results Reference
result
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Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
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