Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Recruiting now · Not applicable
Conditions studied: Lung Cancer, Pulmonary Nodule, Solitary
In brief
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.
Key facts
- Study ID
- NCT05968898
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 300
- Starts
- 2024-01-09
- Expected to finish
- 2030-07-31
- Last updated by the study team
- 2026-06-02
Who can join
Age: 35 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify 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
Where it is running
- Penn Medicine University City — Philadelphia, Pennsylvania, United States (enrolling)
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
- Penn Medicine Washington Square — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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