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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a computer tool that studies CT images changes how doctors care for lung nodules, or small spots in the lungs. It compares usual care with usual care plus the tool. It is for adults ages 35–89 with lung nodules 8–30 mm wide who are seen at Penn Medicine lung nodule clinics.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 35–89 years old.
  • You are scheduled for a visit at a Penn Medicine lung nodule clinic.
  • A CT scan within 60 days of your first clinic visit found a new lung nodule 8–30 mm wide. It is solid or partly solid, and it is not clear whether it is cancer.
  • Your chest CT images meet the requirements for the Optellum Virtual Nodule Clinic software.

Who can't join

  • Your chest CT shows enlarged lymph nodes in the middle of your chest or near where airways enter the lungs, measuring more than 10 mm across their shorter side.
  • Your lung nodule has calcium deposits shaped like popcorn, a sign that it is not cancer.
  • Your lung nodule looks entirely hazy on CT, with no solid part.
  • Your lung nodule was seen on a CT scan more than 60 days before your latest CT scan.
  • You have more than one lung nodule 8–30 mm wide that may or may not be cancer.
  • You have had lung cancer.
  • You have had active cancer within the past 5 years.
  • You have an implant in your chest that makes the lung nodule hard to see.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (3)

PA