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NCT07360145Active, not recruiting

Intelligent Support for Radiological Reporting of Lung Neoplasms

Intelligent Support for Radiological Reporting of Lung Neoplasms - SPOILERS Study

Source: ClinicalTrials.gov · Last updated 22 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
329 (actual)
First submitted
14 Jan 2026
Start date
Mar 2024
Primary completion date
Mar 2025
Lead sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Diseases
Lung cancer
NCT number
NCT07360145

What you commit to

  • Study type: Observational
  • Participants enrolled: 329
  • From Mar 2024 to the primary completion date, Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Previous cancer

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SSD Laboratori di Ricerca (DAIRI) - AOU Alessandria
Coordinator of this site? Confirm its status
AlessandriaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.