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OpenTrials
Enrolling by Invitation

NCT Number: NCT06512142

Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution

Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.

Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.

Validation of the proposed algorithm by comparison with medical diagnosis.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Victor Babes" University Hospital

Timișoara, Timiș County, Romania

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must be diagnosed with COPD and/or asthma and/or pulmonary neoplasm and/or secondary pulmonary, pleural or mediastinal determinations, suspected or confirmed, according to ICD-10.
  • Patients will be included regardless of the type of hospitalization, continuous or day.
  • The existence of freely expressed consent, carried out according to Ethics standards professional (from the observation sheet).

For stage 2

  • The use of HRCT images, in DICOM format, with a maximum cup thickness of 1.5 mm and with an average of 250 cups; no image acquisition errors;
  • Imaging monitoring at a time interval;.
  • Respiratory function evaluation data available: spirometry +/- the factor of gaseous diffusion (DLco);

Exclusion criteria

For both stages:

  • Patients who do not have a stable real domicile (eg social cases) or are not from the Timis county

For stage 2

  • Patients who do not have HRCT images available or cannot be followed.
  • Patients who have insufficient quality HRCT images.
  • Patients who have a history of lung surgery.
  • Patients who have a history of allergies to contrast agents used in imaging HRCT.

Treatment and study plan

Primary outcomes

  1. Correlation between lung diseases and pollution

    Time frame: December 2023 - December 2024

    Establishing the relationship between the incidence and exacerbation of lung diseases (COPD, acute bronchitis, and pulmonary or pleural neoplasms) and pollution levels through geospatial and temporal analysis at the city /county level

  2. Development of a diagnostic algorithm

    Time frame: September 2024 - March 2024

    Creating an accurate, computer-assisted HRCT imaging diagnostic tool designed to detect early tomographic lesions and evaluate the progression speed of these lesions in patients with the mentioned pathologies.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy "Victor Babes" Timisoara

Other

Registry information

Acronym: SmartLungs

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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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