Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07517393

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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

Location status: Recruiting

Location contact

Elisa Roca, MD

CONTACT

[email protected]

+39 0456444193

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged ≥ 18 years who will perform a smdc photon count chest CT scan
  • written informed consent.

Exclusion criteria

  • Lack of information regarding anamnestic data
  • any reason why the investigator deems the patient unenrollable in the practice.

Treatment and study plan

Primary outcomes

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

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

    Number of pulmonary nodules

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

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

    Number of thoracic malignancies

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

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

    Number of non-oncological pulmonary diseases

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

Sponsors and collaborators

Lead sponsor

Casa di Cura Dott. Pederzoli

Other

Registry information

Official study title

LUCE: LUng Cancer (r)Evolution

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.