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OpenTrials
Active, Not Recruiting

NCT Number: NCT04676594

Genentech Validation Tool for Pulmonary Fibrosis

Radiology is an important component of the multidisciplinary team. The primary goal of this project will be to create a tool using findings on chest computed tomography (CT) for nearly 300 patients with the most common types of fibrosis. The tool will be tested using chest CT scans of an additional 100 patients with the 3 most common diagnoses of fibrosis. The second objective will be to further validate the tool by performing a reader study with 3 co-investigating radiologists and ask them to look at 100 CT scans of patients with fibrosis without tool and then with tool and see if accuracy of diagnosis improves compared to the working diagnosis when using the tool.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Who can participate

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

Inclusion criteria

  • Retrospective review of adults (age > 21) with diagnosis of pulmonary fibrosis on chest CT and a pulmonologist report in electronic medical record confirming the working diagnosis from 1/1/2010 through 7/1/2019.

Exclusion criteria

  • Failure to meet inclusion criteria including age < 21 and lack of a pulmonologists report in the medical record with a working diagnosis of patient's type of pulmonary fibrosis.

Treatment and study plan

Primary outcomes

  1. Associations Between Patterns for CT Scan Features

    Time frame: Up to 6 months

    Creation of the radiologic diagnostic tool will be identified via statistical analysis of patterns for CT scan features. The patterns will be characterized using latent class analysis (LCA) and the demographic factors that are predictive of each pattern will be identified. Associations between patterns for CT scan features identified using LCA and the disease diagnosis will then be assessed using the Fisher's exact test.

Secondary outcomes

  1. Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool

    Time frame: Up to 6 months

    The cumulative number of accurate (correct) diagnoses of fibrosis type (interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), or chronic hypersensitivity pneumonitis) without the diagnostic tool. Each assessment will be coded as correct or incorrect by comparing to the true disease diagnosis.

  2. Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool

    Time frame: Up to 6 months

    Cumulative number of accurate (correct) diagnoses of fibrosis type (interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), or chronic hypersensitivity pneumonitis) with the diagnostic tool. Each assessment will be coded as correct or incorrect by comparing to the true disease diagnosis.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2020
Registry last updated
Nov 10, 2025

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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