Status:
RECRUITING
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Lung Cancer
Pulmonary Nodule, Solitary
Eligibility:
All Genders
35-89 years
Phase:
NA
Brief Summary
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. Adul...
Detailed Description
Accurate malignancy risk stratification of pulmonary nodules (PNs) is critical to ensuring that cancer is diagnosed in a timely manner and patients do not undergo unnecessary diagnostic procedures. Pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05968898
Start Date
January 9 2024
End Date
December 31 2027
Last Update
June 6 2025
Active Locations (3)
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1
Penn Medicine University City
Philadelphia, Pennsylvania, United States, 19104
2
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
3
Penn Medicine Washington Square
Philadelphia, Pennsylvania, United States, 19107