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NCT Number: NCT03305380

Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth

The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

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Key information

Conditions

Stage IV Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuyderland Medical Center, Heerlen, Netherlands

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About this study

Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer

Exclusion criteria

  • The opposite of the above

Treatment and study plan

No interventions

Other

As this is a patient registry, there are no interventions.

Primary outcomes

  1. Cause of pneumonitis

    Time frame: 6 months

    Determining cause of the pneumonitis by medical status of the patient

Secondary outcomes

  1. Predictive accuracy of radiomics for determining the cause of pneumonitis

    Time frame: 6 months

    Three subgroups of immune checkpoint induced pneumonitis:

    • Immune checkpoint-induced pneumonitis from tumour progression
    • Immune checkpoint-induced pneumonitis from other types of pneumonitis
    • Patients with interstitial lung disease that are at risk to develop immune checkpoint-induced pneumonitis and those who are not.

    Radiomics will be used to predict the cause of pneumonitis

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University Medical Center
  • Zuyderland Medical Centre

Registry information

Official study title

Radiomics to 1. Identify Patients at Risk for Developing Pneumonitis, 2. Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and 3. Distinguish Tumour Pseudo-progression From Real Tumour Growth, in Patients With Non-small Cell Lung Cancer Treated With Anti-PD1 or Anti-PD-L1

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2017
Registry last updated
Sep 16, 2021

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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