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This research study aims to retrospectively and prospectively analyze the clinical, anamnestic, functional, biological data of patients who have performed or will perform non-contrast chest photon count CT.
The use of contrast medium is evaluated by the physician. Main objective The study aims to understand how many people who undergo non-contrast photon-counting chest CT have: lung nodules, chest tumors, and other non-cancerous lung diseases.
Secondary objectives
The enrollment phase will last 12 months and will begin with the approval of the study. At this stage, clinical data already present in the patient's medical record and data relating to the photon count CT examination will be collected. After the enrollment phase, the patient will be observed for a further total duration of 10 years: in particular, a follow-up visit will be arranged at two, five and ten years. More specifically, if there are no radiological elements that require scheduling a visit to the center, the patient will be contacted by telephone for a telematic update of the data. If, however, pulmonary alterations are identified during the study, the patient will be referred to the Reference Operating Unit, as per clinical practice, to continue with the most appropriate personalized diagnostic-therapeutic process. In these cases, the patient will be contacted by telephone and an appointment with the institution will be suggested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who performed a non-contrast photon count chest CT scan | The enrollment phase of the subjects will last 12 months and will begin with the approval of the study. During the following year, all the data collected from a statistical, mathematical, and artificial intelligence perspective will be analyzed. The data collected are anamnestic, functional where available, biological and radiological data. Following the enlistment phase, subjects will be observed for a total duration of 10 years: in particular, a follow-up visit will be arranged at two, five and ten years. More specifically, if there are no radiological elements that require specific follow-ups, the subject will be contacted by telephone for a telematic update of the data. If, however, pulmonary alterations are identified during the study, the patient will be referred to the Reference Operating Unit, as per clinical practice, to continue with the most appropriate personalized diagnostic-therapeutic process. |
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| Measure | Description | Time Frame |
|---|---|---|
| Describe the frequency of patients performing chest photon counting CT without mdc with pulmonary nodules | Number of pulmonary nodules | through study completion, an average of 1 year |
| Describe the frequency of thoracic malignancies in subjects performing chest photon counting CT without mdc. | Number of thoracic malignancies | through study completion, an average of 1 year |
| Describe the frequency of non-oncological pulmonary diseases of subjects performing chest photon counting CT without mdc. | Number of non-oncological pulmonary diseases | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the AI-based lung digital twin model measured by mean absolute error (MAE) between model-predicted and observed pulmonary function parameters (FEV1, FVC, DLCO) | through study completion, an average of 1 year | |
| Change in lung structural abnormalities measured by quantitative CT parameters (lung density, lung volume, lesion size) |
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Inclusion Criteria:
Exclusion Criteria:
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The population of this study consists of all patients who perform the Photon Counting Computed Tomography
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale P. Pederzoli Casa di Cura Privata S.p.A. | Recruiting | Peschiera del Garda | Verona | 37019 | Italy |
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| through study completion, an average of 1 year |
| Association between lung imaging abnormalities and clinical, biological, and laboratory variables assessed by multivariable regression analysis | Baseline to 12 months |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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