NCT05968898Recruiting
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 9 Jan 2024
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Lung cancer
- NCT number
- NCT05968898
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 9 Jan 2024 to the primary completion date, 31 Jul 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PN previously seen on CT imaging \>60 days prior to most recent CT
- History of active cancer within the previous 5 years
- Presence of a thoracic implant that impedes PN visualization
Other illness
- Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
- History of lung cancer
Other
- 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)
- More than one indeterminate PN 8-30mm in maximal diameter
Who the study is looking for
- 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
Age in the registry: 35 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn Medicine University City Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Penn Medicine Washington Square Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Perelman Center for Advanced Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.