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

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules

Who can join

Ages 35 to 89 · All sexes

Inclusion Criteria:

1. Male or female, aged 35-89 years
2. Scheduled to be evaluated at a UPHS PN clinic
3. Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit
4. Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software

Exclusion Criteria:

1. Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (\>10mm in maximal short-axis diameter on axial CT images)
2. PNs with popcorn calcification (consistent with benign etiology)
3. Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
4. PN previously seen on CT imaging \>60 days prior to most recent CT
5. More than one indeterminate PN 8-30mm in maximal diameter
6. History of lung cancer
7. History of active cancer within the previous 5 years
8. Presence of a thoracic implant that impedes PN visualization

About the study

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.

What is being tested

• Optellum Virtual Nodule Clinic (device)

Sponsor: Abramson Cancer Center at Penn Medicine · Participants: 300 · Started: Jan 9, 2024

Contact the study team

• Roger Y. Kim, MD, MSCE · Phone: 215-662-3677
• Anil Vachani, MD, MSCE · Phone: 215-573-7931

Official record on ClinicalTrials.gov — NCT05968898

Locations in the U.S.

Conditions

• Lung Cancer

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.