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OpenTrials
Active, Not Recruiting

NCT Number: NCT07360145

Intelligent Support for Radiological Reporting of Lung Neoplasms

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SSD Laboratori di Ricerca (DAIRI) - AOU Alessandria

Alessandria, Piedmont, 15121, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Evidence of pulmonary nodule documented radiologically by chest CT scan
  • Presence of CT scan report
  • Presence of histological report (pulmonary nodule biopsy)
  • Presence of written informed consent, signed

Exclusion criteria

  • Previous cancer
  • Previous lung surgery
  • Previous radiation therapy and/or chemotherapy

Treatment and study plan

Collection of variables identified for the study

Other

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.

Primary outcomes

  1. Development of a AI computer model

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

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

Secondary outcomes

  1. Automatic generation of results by the AI model

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

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Intelligent Support for Radiological Reporting of Lung Neoplasms - SPOILERS Study

Acronym: SPOILERS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 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.

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