Using AI to improve diagnosis of lung nodules
Official title: Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
Run by Abramson Cancer Center at Penn Medicine · NCT05968898 · Data updated 2026-11-12
This study is testing if a new computer tool can help doctors better diagnose lung nodules in adults and improve their treatment decisions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 89 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Status | Recruiting |
| Started | January 9, 2024 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2030 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT05968898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 35-89 with newly discovered solid or part-solid pulmonary nodules measuring 8-30mm.
✕Probably not a fit
Patients with benign nodules, a history of lung cancer, or those with certain imaging characteristics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a radiomics-based computer-aided diagnosis (CAD) tool in managing pulmonary nodules (PNs) compared to standard care. Adults aged 35-89 with newly discovered PNs measuring 8-30mm will be randomly assigned to receive either usual care or usual care plus the CAD tool. The goal is to enhance malignancy risk stratification, ensuring timely cancer diagnosis while minimizing unnecessary procedures. Participants will be monitored to assess how the CAD tool influences clinical decision-making.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better management of lung cancer, ultimately improving patient outcomes.
How similar studies have gone: Preliminary data suggests that similar radiomics-based approaches have shown promise, indicating potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, aged 35-89 years 2. Scheduled to be evaluated at a UPHS PN 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 meeting the technical requirements for compatibility 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 8-30mm in maximal diameter 6. History of lung cancer 7. History of active cancer within the previous 5 years 8. Presence of a thoracic implant that impedes PN visualization
Where it's running
-
Penn Medicine University City
Philadelphia, Pennsylvania, United States Recruiting -
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States Recruiting -
Penn Medicine Washington Square
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Roger Y. Kim, MD, MSCE — University of Pennsylvania
- Study coordinator: Roger Y. Kim, MD, MSCE
- Email: roger.kim@pennmedicine.upenn.edu
- Phone: 215-662-3677
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.