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

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

NCT ID: NCT05968898

Condition: Lung Cancer
Pulmonary Nodule, Solitary

Conditions: Official terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule

Conditions: Keywords:
clinical effectiveness
clinical utility
artificial intelligence
medical decision-making
risk stratification

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Optellum Virtual Nodule Clinic
Description: 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.
Arm group label: Clinician assessment + CAD-based risk stratification

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 35 Years

Maximum age: 89 Years

Healthy volunteers: No

Locations:

Facility:
Name: Penn Medicine University City

Address:
City: Philadelphia
Zip: 19104
Country: United States

Status: Recruiting

Contact:
Last name: Roger Kim, MD, MSCE

Facility:
Name: Perelman Center for Advanced Medicine

Address:
City: Philadelphia
Zip: 19104
Country: United States

Status: Recruiting

Contact:
Last name: Roger Kim, MD, MSCE

Facility:
Name: Penn Medicine Washington Square

Address:
City: Philadelphia
Zip: 19107
Country: United States

Status: Recruiting

Contact:
Last name: Roger Kim, MD, MSCE

Start date: January 9, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Abramson Cancer Center at Penn Medicine
Agency class: Other

Source: Abramson Cancer Center at Penn Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05968898