Thoracic NeoplasmNCT07517393
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 of Thoracic Neoplasm and Pulmonary Nodules, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Neoplasm, Pulmonary Nodules, Non-oncological Pulmonary Pathologies
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento Mar 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study consists of all patients who perform the Photon Counting Computed Tomography
Who may be able to join
- Men or women aged ≥ 18 years who will perform a smdc photon count chest CT scan
- written informed consent.
Who cannot join
- Lack of information regarding anamnestic data
- any reason why the investigator deems the patient unenrollable in the practice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Elisa Roca, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: LUCE: LUng Cancer (r)Evolution
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.
Read more
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.
- Keywords
- Lung, Artificial Intelligence, observational, Photon Counting Computed Tomography, thoracic malignancies
- Medical subject headings
- Thoracic Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the frequency of patients performing chest photon counting CT without mdc with pulmonary nodules
Number of pulmonary nodules
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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)
Measured: through study completion, an average of 1 year
Change in lung structural abnormalities measured by quantitative CT parameters (lung density, lung volume, lesion size)
Measured: through study completion, an average of 1 year
Association between lung imaging abnormalities and clinical, biological, and laboratory variables assessed by multivariable regression analysis
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Primary completionMar 2036 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517393
- Sponsor's protocol ID
- 887CET
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUCE: LUng Cancer (r)Evolution
- ClinicalTrials.gov ID
- NCT07517393
- Acronym / sponsor ID
- 887CET
- Keywords
- Lung, Artificial Intelligence, observational, Photon Counting Computed Tomography, thoracic malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Primary completion
- Mar 2036 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study consists of all patients who perform the Photon Counting Computed Tomography
Key inclusion criteria (2 listed)
- Men or women aged ≥ 18 years who will perform a smdc photon count chest CT scan
- written informed consent.
Key exclusion criteria (2 listed)
- Lack of information regarding anamnestic data
- any reason why the investigator deems the patient unenrollable in the practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
3 secondary outcomes
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
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
Association between lung imaging abnormalities and clinical, biological, and laboratory variables assessed by multivariable regression analysis
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Thoracic Neoplasm
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Neoplasm and Pulmonary Nodules, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.