Using AI to improve diagnosis of lung nodules
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 35 Years to 89 Years |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Trial ID | NCT05968898 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-89 with newly discovered solid or part-solid pulmonary nodules measuring 8-30mm.
Not a fit: Patients with benign nodules, a history of lung cancer, or those with certain imaging characteristics may not benefit from this study.
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 performed: Preliminary data suggests that similar radiomics-based approaches have shown promise, indicating potential for success in this study.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.