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

Maastricht Radiation Oncology

Status: Completed

Conditions: Stage IV Non-small Cell Lung Cancer

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT03305380

BMS Radiomics

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 637 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

637 participants in 2 patient groups

Patients with a pulmonary event

Description:

(under anti-PD1 or anti-PD-L1) This is the first group of the retrospective part of the study.

Treatment:

Other: No interventions

Patients without a pulmonary event

Description:

(under anti-PD1 or anti-PD-L1) This is the second group of the retrospective part of the study.

Treatment:

Other: No interventions