Integrating Artificial Intelligence Into Lung Cancer Screening.

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

Lung cancer (LC) screening using low-dose chest CT (LDCT) has already proven its efficacy.

The mortality reduction associated with LC screening is around 20%, much higher than the reduction in mortality associated with screening for breast, colon or prostate cancers.

Implementing lung cancer screening on a large scale faces two main obstacles:

1. The lack of thoracic radiologists and LDCT necessary for the eligible population (between 1.6 and 2.2 million people in France); 2. The high frequency of false positive screenings: in the NLST trial, more than 20% of the subjects screened were found to have at least one nodule of an indeterminate lung nodule (ILN) whereas less than 3% of ILNs are actually LC.

The gold standard for determining on the benign or malignant nature of a nodule is definitive histology. Otherwise, the evolution of the nodule on serial thoracic imaging is a good alternative. The period of indeterminacy of a nodule can be as long as 24 months in many cases, which can be a source of prolonged and sometimes unjustified anxiety for screening candidates.

The purpose of this randomized controlled study that focuses on LC screening in patients aged 50 to 80 years, who smoked more than 20 packs/ year or stopped smoking less than 15 years ago. Its objective is to determine whether assisting multidisciplinary team (MDT) meetings with an AI-based analysis of screening LDCT accelerates the definitive classification of nodules into malignant or benign.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 50 and 80 years old

active smoker or ex-smoker who quit smoking less than 15 years ago

smoking history of at least 20 pack-years

signature of the informed consent

Disqualifiers

clinical signs suggestive of cancer

recent chest scan (<1 year) for another cause

radiological abnormality requiring follow-up or additional investigations

health problem significantly limiting life expectancy from the clinician's point of view

Trial design

Design model

Parallel

Treatments tested in this trial

  • IA

    Other intervention

    The multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography

  • Not IA

    Other intervention

    The multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography

Treatment groups

2,722 Participants
are divided into 2 treatment groups
Group A: IA GroupExperimental treatment 1 intervention
Group B: Group not IA analysisOther 1 intervention

Trial outcomes

Primary outcomes

1

Diagnosis of lung disease

Elapsed time between lung nodule discovery and MDT decision making.

Time frame
At 3 years

Secondary outcomes

1

Operating characteristics of Ai-based strategy

Time frame
At 3 years

Other outcomes

Sponsors and contacts

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