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Intelligent Support for Radiological Reporting of Lung Neoplasms

Intelligent Support for Radiological Reporting of Lung Neoplasms - SPOILERS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07360145
Acronym
SPOILERS
Enrollment
329
Registered
2026-01-22
Start date
2024-03-23
Completion date
2026-02-15
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Nodules

Brief 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.

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Development of a AI computer modelThrough study completion, an average of 18 monthsDevelopment of a computer model that, through the application of artificial intelligence, is capable of recognizing and differentiating pulmonary nodules.

Secondary

MeasureTime frameDescription
Automatic generation of results by the AI modelThrough study completion, an average of 18 monthsAutomatically generate natural language text describing the results that the AI model has recognized from the data provided to it

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026