What this study is
This is a pragmatic clinical trial that will study the effect of a radiomics-based computer-aided diagnosis (CAD) tool on clinicians' management of pulmonary nodules (PNs) compared to usual care. Adults aged 35-89 years with 8-30mm PNs evaluated at Penn Medicine PN clinics will undergo 1:1 randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care or 2) usual care + use of a radiomics-based CAD tool.
What's being tested
- Optellum Virtual Nodule Clinic
Intervention · DEVICE
The Optellum Virtual Nodule Clinic is an FDA-approved (Class II) device for risk stratification of pulmonary nodules. It uses a convolutional neural network to evaluate CT imaging data to provide an estimate of malignancy risk for indeterminate pulmonary nodules.
Study details
- Official title
- Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Conditions
- Lung Cancer · Pulmonary Nodule, Solitary
- Enrolling
- 300 people
- Starts
- 2024-01-09
- Est. completion
- 2030-07-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 35 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female, aged 35-89 years
- Scheduled to be evaluated at a UPHS PN clinic
- Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit
- Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software
You can't join if
- Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (>10mm in maximal short-axis diameter on axial CT images)
- PNs with popcorn calcification (consistent with benign etiology)
- Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
- PN previously seen on CT imaging >60 days prior to most recent CT
- More than one indeterminate PN 8-30mm in maximal diameter
- History of lung cancer
- History of active cancer within the previous 5 years
- Presence of a thoracic implant that impedes PN visualization
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Roger Kim, MD, MSCE · Contact
Penn Medicine University City
Philadelphia, Pennsylvania, United States
RecruitingPerelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
RecruitingPenn Medicine Washington Square
Philadelphia, Pennsylvania, United States
Recruiting
Study team
Sponsor
Abramson Cancer Center at Penn Medicine
Study ID 10523
Principal investigator
Roger Y. Kim, MD, MSCE
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.