Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-89
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Optellum Virtual Nodule Clinic
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov