Lung NeoplasmNCT01261507
Reader Study of DeltaView™ Chest Radiograph Software
An observational study of Lung Neoplasm, run by Georgetown University at 1 site in United States.
Trial summary
A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Lung Neoplasm
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule
Who may be able to join
- For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas
- For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality
- -
Who cannot join
- Radiologists who assisted by providing cases for review
- For chest radiographs: poor image quality
Trial locations and contacts
1 site in 1 country.
United States1 site
ISIS Research Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current Antero/Posterior (AP/PA) X-ray Image Pair
A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.
- Conditions
- Lung Neoplasm
- Keywords
- lung neoplasm nodule image processing computer-assisted
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Localized Receiver Operating Characteristic (LROC) Comparison
The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as "noise" cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement.
Measured: 1 day
Secondary outcomes (2)
Sensitivity and Specificity
Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.
Measured: 1 day
False Positive Decisions of Radiologists
This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Riverain Medical Group, Miamisburg, OH, BioStat Solutions, Inc., Mt. Airy, MD
- Responsible party
- Principal investigator, Matthew T. Freedman, MD, Georgetown University
- Investigators
- Matthew T Freedman, MD, MBA, Principal investigator, Georgetown UniversityS.-C. Ben Lo, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261507
- Sponsor's protocol ID
- DHF-183-0531A
- Status last verified
- Nov 2015
- First submitted
- 14 Dec 2010
- Last updated
- 1 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current Antero/Posterior (AP/PA) X-ray Image Pair
- ClinicalTrials.gov ID
- NCT01261507
- Acronym / sponsor ID
- DHF-183-0531A
- Conditions
- Lung Neoplasm
- Keywords
- lung neoplasm nodule image processing computer-assisted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Riverain Medical Group, Miamisburg, OH, BioStat Solutions, Inc., Mt. Airy, MD
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.
Study design
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule
Key inclusion criteria (3 listed)
- For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas
- For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality
- -
Key exclusion criteria (2 listed)
- Radiologists who assisted by providing cases for review
- For chest radiographs: poor image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Localized Receiver Operating Characteristic (LROC) Comparison
Time frame: 1 day
The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as "noise" cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement.
2 secondary outcomes
Sensitivity and Specificity
Time frame: 1 day
False Positive Decisions of Radiologists
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew T Freedman, MD, MBA principal investigator
Georgetown University
S.-C. Ben Lo, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localized Receiver Operating Characteristic (LROC) Comparison (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2015.