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Official title Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
ClinicalTrials.gov ID: NCT05968898
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 89
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.