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

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedOptellum Virtual Nodule Clinic

The study team can explain what participation involves.

Who it may be forLung Cancer · Pulmonary Nodule, Solitary

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Abramson Cancer Center at Penn Medicine

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Not applicable
Sponsor: Abramson Cancer Center at Penn Medicine
Interventions being studied: Device: Optellum Virtual Nodule Clinic

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Penn Medicine University CityPhiladelphia, Pennsylvania
Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania
Penn Medicine Washington SquarePhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 2, 2026. Always confirm current availability with the study team.

View original record ↗