Pneumothorax
Conditions
Interventions
Gold Standard:The reference standard was established by thoracic radiologists (A, B, and C, with 10, 15, and 20 years of experience in thoracic radiology. The reference standard for quantifying pneumo
Index test:Primary EndpointComparison of the diagnostic performance between PTX-AI v1 and radiology residents for pneumothorax detection, using the following metrics: sensitivity, specificity, positiv
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet criteria 1+2+3+4+6 or 1+2+3+5+6: 1) Have signed an informed consent form; 2) Be aged between 18 and 80 years; 3) Have a pathologically confirmed diagnosis of colon or rectal cancer; 4) Patients with a clinical and imaging diagnosis of a lung tumour, where imaging and follow-up cannot confirm metastasis, and who require a percutaneous needle biopsy to confirm the pathology; or patients who require tissue samples to be taken for a clinical trial; 5) Patients with a clinical, imaging or pathological diagnosis of lung metastasis who require percutaneous local ablation; 6) Patients who have undergone at least one post-operative chest X-ray.
Exclusion criteria
Exclusion criteria: Subjects should not participate in the trial if any of the following conditions apply: 1. Patients with severe cardiac or pulmonary insufficiency who, in the investigator’s assessment, are unsuitable for participation in this clinical trial; 2. Patients with marked coagulation abnormalities; 3. Patients with obvious infectious lesions along the intended puncture site; 4. Patients with significant pleural effusion on the affected side; 5. Patients requiring management of post-operative complications such as haemorrhage, air embolism, or cardiovascular or cerebrovascular events; 6. Pregnant or breastfeeding women; 7. Patients with cognitive impairment; 8. Patients assessed by the investigator as unlikely to cooperate adequately with this trial; 9. Other circumstances deemed by the investigator to render the patient unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy for pneumothorax detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy of pneumothorax segmentation;Dice coefficient;Accuracy of pneumothorax volume measurement;Degree of deviation from the gold standard (volume of pneumothorax on CT scan images); | — |
Countries
China
Contacts
Public ContactHe Xinhong
Fudan University Shanghai Cancer Center
Outcome results
None listed