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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Pulmonary Nodule, Solitary; Lung Cancer

Treatments: Device: Optellum Virtual Nodule Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT05968898

10523

Details and patient eligibility

About

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.

Full description

Accurate malignancy risk stratification of pulmonary nodules (PNs) is critical to ensuring that cancer is diagnosed in a timely manner and patients do not undergo unnecessary diagnostic procedures. Preliminary data suggests that a radiomics-based lung cancer prediction (LCP) computer-aided diagnosis (CAD) tool is effective in risk stratifying PNs and may improve clinicians' PN management decisions. This is a pragmatic clinical trial evaluating the effect of this CAD tool on clinicians' management of PNs compared to usual care. Individuals eligible for this study will include adults aged 35-89 years who are scheduled to be evaluated at a Penn Medicine PN clinic for a newly discovered PN 8-30mm in maximal diameter on CT imaging. Exclusion criteria include lack of CT imaging data at the time of index clinic visit, thoracic lymphadenopathy by CT size criteria, presence of pulmonary masses (>3cm in maximal diameter), PNs with popcorn calcification (consistent with benign etiology), pure ground-glass subsolid PNs, a history of lung cancer, and history of any active cancer within 5 years. Enrolled participants will undergo 1:1 stratified randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care (clinician assessment) or 2) clinician assessment + CAD-based risk stratification using the LCP-CAD tool. The control arm will be usual care, defined as routine clinician assessment of PN malignancy risk. In the experimental arm, clinicians will be provided a report with the CAD tool estimate of malignancy risk for the PN being evaluated.

Enrollment: 300 estimated patients

Sex: All

Ages: 35 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Usual care (clinician assessment)

No Intervention group

Description:

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.

Clinician assessment + CAD-based risk stratification

Experimental group

Description:

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.

Treatment:

Device: Optellum Virtual Nodule Clinic