Pulmonary nodule
Conditions
Interventions
Gold Standard:The clinical pathological diagnosis results of pulmonary nodules
Index test:Test group: CT readings conducted jointly by radiologists using AI-assisted diagnostic software
Control group: CT readings conducted independently by radiologists
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender; 2. Pulmonary nodules detected on chest CT, with corresponding pathological reports and/or surgical records that accurately locate the nodules with pathological results on CT images; 3. The CT scan must be the most recent one before surgery, with a time interval of no more than one month; 4. Pulmonary nodules on chest CT must be >=4 mm and =16.
Exclusion criteria
Exclusion criteria: 1. If no nodules on a pathological report can be accurately located on the CT scan, the case will be excluded; 2. Incomplete chest CT scan range; CT images taken after surgery or biopsy; poor image quality with severe metal or respiratory artifacts affecting the reading; 3. Clinically diagnosed metastatic lesions; 4. Participants deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ROC-AUC (paricipants level); | — |
Secondary
| Measure | Time frame |
|---|---|
| ROC-AUC (nodule level);The sensitivity, specificity, and accuracy (at the nodule level) of malignancy determination for pulmonary nodules in the test group and the control group;The sensitivity, specificity, and accuracy (at the participant level) of malignancy determination for pulmonary nodules in the experimental group and the control group;The sensitivity and specificity (at the nodule level) of the software in determining the malignancy of pulmonary nodules in the subjects;The accuracy of the software in determining the location of pulmonary nodules (at the nodule level);The accuracy of the software in determining the density of pulmonary nodules (nodule level);Subjective evaluation of software functionality;Subjective evaluation of software usability; | — |
Countries
China
Contacts
Public ContactZhengyu Jin; Nan Hong
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Peking University People's Hospital
Outcome results
None listed