Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCasa di Cura Dott. Pederzoli

About this trial

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

* Analyze the data with the help of artificial intelligence to create a "digital twin" of the lung, that is, a virtual copy of the lung that allows you to study and simulate the behavior of the lung for research and analysis purposes, without directly intervening on the patient. * Follow any suspicious lung changes over time to understand how they change and whether they are linked to clinical, biological, or laboratory parameters.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women aged ≥ 18 years who will perform a smdc photon count chest CT scan

written informed consent.

Disqualifiers

Lack of information regarding anamnestic data

any reason why the investigator deems the patient unenrollable in the practice.

Trial population

The population of this study consists of all patients who perform the Photon Counting Computed Tomography

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Patients who performed a non-contrast photon count chest CT scan

Trial outcomes

Primary outcomes

1

Describe the frequency of patients performing chest photon counting CT without mdc with pulmonary nodules

Number of pulmonary nodules

Time frame
through study completion, an average of 1 year
2

Describe the frequency of thoracic malignancies in subjects performing chest photon counting CT without mdc.

Number of thoracic malignancies

Time frame
through study completion, an average of 1 year
3

Describe the frequency of non-oncological pulmonary diseases of subjects performing chest photon counting CT without mdc.

Number of non-oncological pulmonary diseases

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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)

Time frame
through study completion, an average of 1 year
2

Change in lung structural abnormalities measured by quantitative CT parameters (lung density, lung volume, lesion size)

Time frame
through study completion, an average of 1 year
3

Association between lung imaging abnormalities and clinical, biological, and laboratory variables assessed by multivariable regression analysis

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

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