NCT05968898 · Abramson Cancer Center at Penn Medicine
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
(ARCADES)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female, aged 35-89 years
- Scheduled to be evaluated at a UPHS PN clinic
- Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit
- Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software
Exclusion criteria
- Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (\>10mm in maximal short-axis diameter on axial CT images)
- PNs with popcorn calcification (consistent with benign etiology)
- Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
- PN previously seen on CT imaging \>60 days prior to most recent CT
- More than one indeterminate PN 8-30mm in maximal diameter
- History of lung cancer
- History of active cancer within the previous 5 years
- Presence of a thoracic implant that impedes PN visualization
Where
- Philadelphia, Pennsylvania
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations