CClinicalTrials.gg
Active, not recruitingNCT07360145SPOILERSUpdated Jan 22, 2026

Intelligent Support for Radiological Reporting of Lung Neoplasms

An observational study in Pulmonary Nodules, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
329
Ages
18 Years and older
Sex
All
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Study summary

Lung cancer is one of the most common cancers and has one of the worst prognoses, mainly due to the difficulty of early diagnosis. In Italy, there are an estimated 41,000 new cases each year, and in 2021, the disease was responsible for approximately 34,000 deaths. The social impact is significant, as the disease is often diagnosed at an advanced stage, when the chances of survival are reduced: the 5-year survival rate is around 18% in advanced stages, while it can reach 90% if diagnosed at an early stage.

Early-stage lung cancer mainly manifests itself in the form of pulmonary nodules, which can be detected by computed tomography (CT). However, the diagnosis of these nodules often requires invasive procedures, such as bronchoscopy, CT-guided needle biopsy, or surgical biopsies, which affect patients' quality of life and healthcare costs. For this reason, the ability to accurately distinguish between benign and malignant nodules is a central theme in clinical research.

In recent years, artificial intelligence, particularly deep learning techniques, has shown considerable potential in supporting CT screening. Results show that AI can achieve performance superior to that of individual radiologists and comparable to that of a multidisciplinary team, using histological reports as a diagnostic reference. This confirms the value of AI as a tool to support clinical decision-making.

Considering the multimodal nature of clinical data (images, text reports, diagnostic tests), there is growing interest in models capable of integrating multiple sources of information. In this context, the research project aims to develop a system capable of automatically recognizing pulmonary nodules and generating natural language text descriptions of the findings.

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Conditions studied

  • Pulmonary Nodules
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In context

Multiple Pulmonary Nodules

188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.

This study's enrollment of 329 is above the median of 255 across 87 observational studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 36 studies on the registry; 13 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who have pulmonary nodules on computed tomography (CT) evaluation and who undergo biopsy are expected to be enrolled.

Inclusion criteria

  1. Age ≥18 years
  2. Evidence of pulmonary nodule documented radiologically by chest CT scan
  3. Presence of CT scan report
  4. Presence of histological report (pulmonary nodule biopsy)
  5. Presence of written informed consent, signed

Exclusion criteria

Exclusion Criteria:

  1. Previous cancer
  2. Previous lung surgery
  3. Previous radiation therapy and/or chemotherapy
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
329 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with pulmonary nodules

    Patients who have pulmonary nodules on computed tomography (CT) evaluation and who undergo biopsy will be enrolled.

    Other: Collection of variables identified for the study

Interventions

  • OtherCollection of variables identified for the study

    The intervention involves enrolling patients with lung nodules and collecting clinical data, anonymizing it, pre-process CT images and prepare them for use in training artificial intelligence models, ensuring clinical validation and ethical compliance.

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What researchers measure

Primary outcomes

  1. Development of a AI computer model

    Development of a computer model that, through the application of artificial intelligence, is capable of recognizing and differentiating pulmonary nodules.

    Time frame: Through study completion, an average of 18 months

Secondary outcomes

  1. Automatic generation of results by the AI model

    Automatically generate natural language text describing the results that the AI model has recognized from the data provided to it

    Time frame: Through study completion, an average of 18 months

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Study locations

1 site
  • SSD Laboratori di Ricerca (DAIRI) - AOU Alessandria
    Alessandria, Piedmont 15121, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07360145
Lead sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Responsible party
Sponsor
First posted
Jan 22, 2026
Start date
Mar 23, 2024
Primary completion
Mar 23, 2025
Completion
Feb 15, 2026 (estimated)
Last update
Jan 22, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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