RecruitingNot Applicable

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES

United States300 participantsStarted 2024-01-09

Plain-language 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. 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.

Who can participate

Age range35 Years – 89 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Appropriate management of pulmonary nodule

Timeframe: 12 months

Trial details

NCT IDNCT05968898

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Roger Y. Kim, MD, MSCE

215-662-3677 roger.kim@pennmedicine.upenn.edu

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