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RecruitingNCT07517393Updated Oct 22, 2026

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)

An observational study in Thoracic Neoplasm, Pulmonary Nodules and Non-oncological Pulmonary Pathologies, sponsored by Casa di Cura Dott. Pederzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Casa di Cura Dott. Pederzoli · Observational

Updated Oct 22, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Thoracic Neoplasm
  • Pulmonary Nodules
  • Non-oncological Pulmonary Pathologies

Keywords

  • Lung
  • Artificial Intelligence
  • observational
  • Photon Counting Computed Tomography
  • thoracic malignancies
03

In context

Thoracic Neoplasms

115 studies on the registry are indexed under Thoracic Neoplasms; 30 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 140 across 25 observational studies indexed under Thoracic Neoplasms.

Browse Thoracic Neoplasms studies →

Lead sponsor

Casa di Cura Dott. Pederzoli is the lead sponsor of 15 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack of information regarding anamnestic data
  • any reason why the investigator deems the patient unenrollable in the practice.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Apr 2026 removed
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Start date Apr 2026 removed
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07517393
Lead sponsor
Casa di Cura Dott. Pederzoli
Responsible party
Sponsor
First posted
Apr 8, 2026
Primary completion
Mar 2036 (estimated)
Completion
Mar 2036 (estimated)
Last update
Oct 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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