Actively Recruiting
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-06-06
300
Participants Needed
3
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 35-89 years
- Scheduled to be evaluated at a UPHS pulmonary nodule clinic
- Newly discovered solid or part-solid indeterminate pulmonary nodule 8-30 mm in maximal diameter on CT imaging within 60 days of index clinic visit
- Chest CT imaging meets technical requirements for compatibility with the Optellum Virtual Nodule Clinic software
You will not qualify if you...
- Chest CT imaging showing mediastinal or hilar lymphadenopathy larger than 10 mm in short-axis diameter
- Pulmonary nodules with popcorn calcification indicating benign cause
- Pure ground-glass subsolid pulmonary nodules
- Pulmonary nodule seen on CT imaging more than 60 days before the most recent CT
- More than one indeterminate pulmonary nodule 8-30 mm in maximal diameter
- History of lung cancer
- History of active cancer within the previous 5 years
- Presence of a thoracic implant that prevents visualization of pulmonary nodules
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Penn Medicine University City
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Penn Medicine Washington Square
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
R
Roger Y. Kim, MD, MSCE
CONTACT
A
Anil Vachani, MD, MSCE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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