Recruiting

CAD Tool

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05968898

Conditions

Lung Cancer

Pulmonary Nodule, Solitary

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Optellum Virtual Nodule Clinic

Study Details

Brief 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.

Conditions

Lung Cancer

Pulmonary Nodule, Solitary

Study ID

NCT05968898

Start date

Jan 9, 2024

Status verified date

Jun, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Usual care (clinician assessment)

In the usual care arm, clinicians will evaluate individuals with indeterminate pulmonary nodules as part of routine clinical care. No specific guidance regarding pulmonary nodule risk stratification will provided to evaluating clinicians.

experimental: Clinician assessment + CAD-based risk stratification

In the experimental arm, evaluating clinicians will receive a Lung Cancer Prediction report from an artificial intelligence radiomics-based computer-aided diagnosis tool for risk stratification of pulmonary nodules.

Interventions

Optellum Virtual Nodule Clinic

The Optellum Virtual Nodule Clinic is an FDA-approved (Class II) device for risk stratification of pulmonary nodules. It uses a convolutional neural network to evaluate CT imaging data to provide an estimate of malignancy risk for indeterminate pulmonary nodules.

Primary outcome measure

  • Appropriate management of pulmonary nodule [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Roger Y. Kim, MD, MSCE

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

Anil Vachani, MD, MSCE

215-573-7931avachani@pennmedicine.upenn.edu

Locations

Penn Medicine University City

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Penn Medicine Washington Square

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • clinical effectiveness
  • clinical utility
  • artificial intelligence
  • medical decision-making
  • risk stratification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-02.