← Back to Search

Computer-Aided Diagnosis Tool for Lung Nodules (ARCADES Trial)

N/A

Recruiting

Led By Roger Y. Kim, MD, MSCE

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a computer-aided diagnosis tool can help doctors manage lung nodules. Adults with lung nodules will be randomly assigned to either receive the usual care or the usual care plus

Who is the study for?

Adults aged 35-89 with newly discovered solid pulmonary nodules (8-30mm) on CT scans, scheduled for evaluation at a pulmonary nodule clinic. Participants must have CT imaging compatible with the Optellum Virtual Nodule Clinic software available by their first clinic visit.

What is being tested?

This trial is testing the impact of a radiomics-based computer tool called Optellum Virtual Nodule Clinic on doctor's decisions in managing lung nodules, compared to standard care without this tool. Patients are randomly placed into one of these two groups.

What are the potential side effects?

Since this trial involves a diagnostic tool rather than medication or invasive procedures, traditional side effects are not expected. However, there may be indirect consequences based on changes in clinical management resulting from the use of the CAD tool.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Appropriate management of pulmonary nodule

Secondary study objectives

Adverse events

Diagnostic yield

Healthcare costs

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Clinician assessment + CAD-based risk stratificationExperimental Treatment1 Intervention

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.

Group II: Usual care (clinician assessment)Active Control1 Intervention

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.

Do I qualify?Apply below to find out