← Back to Search

Clinician assessment + CAD-based risk stratification for Lung Cancer (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

ARCADES Trial 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.Check my eligibility

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.See study design

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.

ARCADES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Appropriate management of pulmonary nodule

Secondary outcome measures

Adverse events

Diagnostic yield

Healthcare costs

+1 more

ARCADES 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

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,344 Total Patients Enrolled

Roger Y. Kim, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently eligible to apply for participation in this ongoing medical study?

"Indeed, as indicated on clinicaltrials.gov, this trial is currently actively seeking eligible candidates. The study was initially posted for recruitment on January 8th, 2024 and underwent the most recent update on January 5th, 2024."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is actively seeking eligible participants. The trial was initially posted on January 8th, 2024 and has recently undergone an update on January 5th, 2024. A total of three locations are involved in recruiting approximately 300 individuals for this study."

Answered by AI

Is the clinical trial inclusive of participants who are below 18 years old?

"To be eligible for this study, individuals must fall within the age range of 35 to 89. It is worth noting that there are currently 15 clinical trials available specifically for participants under the age of 18, while there are a total of 408 trials catering to patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Roger Y. Kim 2024. "Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968898.