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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05968898
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Optellum Virtual Nodule Clinic — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Penn Medicine University CityPhiladelphiaPennsylvania19104
Roger Kim, MD, MSCE
Penn Medicine Washington SquarePhiladelphiaPennsylvania19107
Roger Kim, MD, MSCE
Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Roger Kim, MD, MSCE

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By condition
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By research site
Penn Medicine University City· Philadelphia, PAPenn Medicine Washington Square· Philadelphia, PAPerelman Center for Advanced Medicine· Philadelphia, PA

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