Lung CancerNCT00906789

Testing of Computer Aided Detection Software for Riverain Medical Group

An observational study of Lung Cancer, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Lung Cancer
What is being tested?: Software
Type of treatment: Lifestyle or therapy programme
How many people: 15 participants
Where: 1 siteUnited States
Study dates: May 2009to Jun 2010
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Radiologists in active clinical practice who are not subspecialists in chest radiology

Who may be able to join

US American Board of Radiology Certified Radiologists in active clinical practice

Who cannot join

Specialists in pulmonary or chest or cardio-pulmonary radiology Prior membership on expert panels for this study who prepared cases Current or recent colleagues or trainees (within 10 years) of the Principal Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

ISIS Imaging Science Research Center, Georgetown University
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

This is a clinical trial using retrospective data of two different software devices developed by Riverain Medical Group: Softview and OnGuard 5.0. The two studies will be run concurrently. Riverain Medical Group's computer systems are designed to assist radiologists in their identification of lung cancer on chest radiographs. The current machine received FDA Pre-Market Approval. This is to test two new software approaches.

Read the detailed description

In 2000, data was presented to the FDA to demonstrate that a new system for computer analysis could assist radiologists in the detection of small lung cancers on chest radiographs. Radiologists using the system showed a statistically significant improvement in lung cancer detection rate when they used the system, compared to their interpretation of chest radiographs when they did not use the computer system. This study, along with other supporting data, resulted in the FDA giving Pre-Market Approval for the system.

The system has undergone several improvements in software and hardware, and it is now intended to test two different software systems to determine whether radiologists using the systems can improve their detection of lung cancer on chest radiographs.

One of these systems processes the chest radiograph to decrease the emphasis given to the shadow of the ribs and thereby enhances the ability of radiologists to detect disease in the lungs. The second system performs a series of evaluations on chest radiographs and, based on a complex system of analysis, points to locations on the chest radiograph that contain solitary pulmonary nodules having the characteristics of primary lung cancer or solitary metastases of cancer to the lungs.

This will be a test of radiologists to determine the degree of improvement, if any, that results when they interpret chest radiographs that may or may not have cancer, first interpreted without the computer and, second, with the images output by the software.

Conditions: Lung Cancer
Being tested: Software
Keywords: Lung Cancer, Chest Radiograph, Computer-aided Detection, Image processing
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SoftwareBehavioural
Also called SoftView 2.0, OnGuard 5.1
This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested

Study groups in NCT00906789
Study group	Role	What they receive
Radiologists		Radiologists who have certification by the American Board of Radiology Receives: Behavioral: Software

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.
Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer.
A larger number, if statistically significant, indicates that that method is better.
Measured: Three days of experiment over 3-5 months, varied by participant

Secondary outcomes (1)

Sensitivity and Specificity Using SoftView Software
Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used.
Measured: Three days of experiment over 3-5 months, varied by participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jun 2010

First posted21 May 2009 (estimated)
Study startMay 2009
Primary completionJun 2010
Study completionJun 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00906789
Sponsor's protocol ID: Riverain SV 2.0.1 and OG5.0
Other IDs: Softview 2.0.1, OnGuard 5.0
Status last verified: Aug 2014
First submitted: 5 May 2008
Last updated: 1 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Freedman MT, Lo SC, Seibel JC, Bromley CM. Lung nodules: improved detection with software that suppresses the rib and clavicle on chest radiographs. Radiology. 2011 Jul;260(1):265-73. doi: 10.1148/radiol.11100153. Epub 2011 Apr 14.
PubMed 21493789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing of Computer Aided Detection Software for Riverain Medical Group
ClinicalTrials.gov ID: NCT00906789
Acronym / sponsor ID: Riverain SV 2.0.1 and OG5.0
Conditions: Lung Cancer
Keywords: Lung Cancer, Chest Radiograph, Computer-aided Detection, Image processing
Study type: Observational
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Georgetown UniversityUniversity, hospital or other
Collaborators: Riverain Technologies
Study start: May 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 21 May 2009 (estimated)
Results: Posted 1 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Number of arms: 1

Arm	Type	Receives
Radiologists	–	Behavioral: SoftwareRadiologists who have certification by the American Board of Radiology

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Radiologists in active clinical practice who are not subspecialists in chest radiology

Key inclusion criteria (1 listed)

US American Board of Radiology Certified Radiologists in active clinical practice

Key exclusion criteria (1 listed)

Specialists in pulmonary or chest or cardio-pulmonary radiology Prior membership on expert panels for this study who prepared cases Current or recent colleagues or trainees (within 10 years) of the Principal Investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SoftwareAlso: SoftView 2.0, OnGuard 5.1This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested	Behavioural	Radiologists

Primary outcome

Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.
Time frame: Three days of experiment over 3-5 months, varied by participant
Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer. A larger number, if statistically significant, indicates that that method is better.

1 secondary outcome

Sensitivity and Specificity Using SoftView Software
Time frame: Three days of experiment over 3-5 months, varied by participant

Results and safety

Results posted to the registry on 1 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiologists	15	15

Primary outcome: Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.

Time frame: Three days of experiment over 3-5 months, varied by participant. Mean (95% Confidence Interval). Unit: unitless

Measure	Radiologists Control for SoftView n = 15	Radiologists Using Softview Software n = 15
Value	0.460 (0.435 to 0.486)	0.558 (0.539 to 0.578)

Radiologists Control for SoftView vs Radiologists Using Softview Software: p = 0.05, Bootstraping

Population analysed: 122 subjects had cancer that potentially could be detected on their chest radiograph. Power analysis showed that sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): No adverse events occurred. Study was subject to the following potential biases: Sample bias; Majority rule bias; Referral Bias, bias from knowledge that this is an experiment; reader order bias; learning bias; Bias from use of new technology, et al

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21493789Freedman MT, Lo SC, Seibel JC, Bromley CM. Lung nodules: improved detection with software that suppresses the rib and clavicle on chest radiographs. Radiology. 2011 Jul;260(1):265-73. doi: 10.1148/radiol.11100153. Epub 2011 Apr 14.

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Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
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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

Ben Lo, Ph.D. study director

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 Cancer, 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 1 inclusion and 1 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 Sep 2014. 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 1 Sep 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?

Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve. (time frame: Three days of experiment over 3-5 months, varied by participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00906789, which also lists 1 linked publication.

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 Sep 2014.