Segmentation of Structural Abnormalities in Chronic Lung Diseases

Sponsor
Hôpital Haut Lévêque (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04760548
Collaborator
Centre National de la Recherche Scientifique, France (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other), University of Cincinnati (Other)
800
1
193.5
4.1

Study Details

Study Description

Brief Summary

Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study

Detailed Description

Three chronic lung diseases will constitute the target of the study, by using retrospective data from each lung disease:

  • Cystic fibrosis

  • Asthma and COPD

  • Interstitial lung diseases

Dedicated algorithms will be developped for each disease condition.

Study Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Segmentation of Structural Abnormalities in Chronic Lung Diseases
Actual Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Feb 17, 2024
Anticipated Study Completion Date :
Feb 17, 2024

Arms and Interventions

Arm Intervention/Treatment
Train dataset

This group is dedicated to developing an automated algorithm

Other: Observational study

Test dataset

This group is dedicated to testing the performance of an automated algorithm

Other: Observational study

Clinical Validation

This group is dedicated to assessing the clinical validity of the measurement in an independent validation cohort

Other: Observational study

Outcome Measures

Primary Outcome Measures

  1. Validity of automated measurement [From date of inclusion until the date of final quantification, assessed up to 12 months]

    Correlations and comparisons with other biomarker of the disease severity

Secondary Outcome Measures

  1. Correlation with pulmonary function test [From date of inclusion until the date of final quantification, assessed up to 12 months]

    Correlation of quantitative measurement with pulmonary function

  2. Longitudinal variation over time [From date of inclusion until the date of final quantification, assessed up to 12 months]

    Comparison of quantitative measurement at two time points

  3. Reproducibility [From date of inclusion until the date of final quantification, assessed up to 12 months]

    Evaluation of measurements when performed twice

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up
Exclusion Criteria:
  • In the Clinical Validation group, patients with exacerbation or part of the other groups

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Haut Leveque Pessac France

Sponsors and Collaborators

  • Hôpital Haut Lévêque
  • Centre National de la Recherche Scientifique, France
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University of Cincinnati

Investigators

  • Study Chair: Francois Laurent, Pr, Hopital Haut Leveque

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital Haut Lévêque, Director, Hôpital Haut-Lévêque
ClinicalTrials.gov Identifier:
NCT04760548
Other Study ID Numbers:
  • SA-AI
First Posted:
Feb 18, 2021
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022