Clinical trial · Observational
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)
LUCE: LUng Cancer (r)Evolution
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-oncological Pulmonary Pathologies | — | UNRESOLVED | — |
| Pulmonary Nodules | — | UNRESOLVED | — |
| Thoracic Neoplasm | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients who performed a non-contrast photon count chest CT scan
- description
- 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.
Primary outcomes (3)
- measure
- Describe the frequency of patients performing chest photon counting CT without mdc with pulmonary nodules
- timeFrame
- through study completion, an average of 1 year
- description
- Number of pulmonary nodules
- measure
- Describe the frequency of thoracic malignancies in subjects performing chest photon counting CT without mdc.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available