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

March 8, 2024 updated by: Roger Y. Kim, Abramson Cancer Center at Penn Medicine

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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), subsolid PNs, and a known history of active cancer. 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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Perelman Center for Advanced Medicine
        • Contact:
          • Roger Kim, MD, MSCE
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine University City
        • Contact:
          • Roger Kim, MD, MSCE
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Penn Medicine Washington Square
        • Contact:
          • Roger Kim, MD, MSCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, aged 35-89 years
  2. Scheduled to be evaluated at a pulmonary nodule 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 compatible 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 8-30 mm in maximal diameter
  6. History of lung cancer
  7. History of active cancer within the previous 5 years
  8. Low-dose CT chest imaging
  9. Presence of a thoracic implant that impedes PN visualization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriate management of pulmonary nodule
Time Frame: 12 months
The composite proportion of benign pulmonary nodules managed with imaging surveillance and malignant pulmonary nodules managed with biopsy or empiric treatment. Final pulmonary nodule diagnosis will be categorized as malignant or benign based on pathologic evaluation. If pathology is unavailable or inconclusive (i.e., the biopsy was non-diagnostic), pulmonary nodule resolution, shrinkage, or diameter stability at 12 months will be defined as a benign diagnosis.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeliness of care
Time Frame: 12 months
For patients with malignant pulmonary nodules, defined as the number of days between the index clinic visit and diagnosis of malignancy and receipt of treatment for malignancy (i.e., surgical resection, radiation therapy).
12 months
Adverse events
Time Frame: 12 months
For patients undergoing biopsy, defined as procedural complications related to pulmonary nodule biopsy.
12 months
Diagnostic yield
Time Frame: 12 months
Using information found in pathology reports, defined as the proportion of biopsies with a definitive histopathologic diagnosis, for each type of diagnostic biopsy procedure.
12 months
Healthcare costs
Time Frame: 12 months
The costs of all imaging studies and diagnostic testing associated with the pulmonary nodule diagnostic process, based on Medicare allowed amounts (amount paid by Medicare and the amount paid by the beneficiary and/or third parties).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Roger Y. Kim, MD, MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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