XENON (133XE) for Radiation-induced lung injury | Lung cancer | Breast cancer

Inclusion criteria

• {"criterion_text":"- Lung and breast cancer having a TNM classification I-IIIa."}
• {"criterion_text":"- Between 50 and 80 years old."}
• {"criterion_text":"- No prior cancer treatment."}
• {"criterion_text":"- Breath hold for 3 seconds"}
• {"criterion_text":"- Patients who are in stable condition or who are not hospitalized in an ICU."}
• {"criterion_text":"- Patients who are not suffering from COPD GOLD IV."}
• {"criterion_text":"- Patients who signed informed consent forms."}

Exclusion criteria

• {"criterion_text":"- No lung or breast cancer having a TNM classification I-IIIa."}
• {"criterion_text":"- Younger than 50 or older than 80 years old."}
• {"criterion_text":"- Received prior cancer treatment."}
• {"criterion_text":"- Cannot perform a 3 s breath hold"}
• {"criterion_text":"- Patients who are in an unstable condition or who are hospitalized in ICU."}
• {"criterion_text":"- Patients who are suffering from COPD GOLD IV."}
• {"criterion_text":"- Patients who did not sign informed consent forms."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study is to quantify radiotherapy-induced functional and anatomical changes by comparing pre- and post-treatment ventilation maps. Radiotherapy-induced changes will be assessed both qualitatively, by visual analysis of differences in lung parenchyma structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps of the lungs), and quantitatively, by computing local differences in ventilation metrics between pre- and post-treatment.","definition_or_measurement_approach":"Assessment by comparing pre- and post-treatment ventilation maps generated using a gas mixture of 30 Vol% Xe in 70 Vol% O2 combined with DECT-imaging; qualitative visual analysis of structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps) and quantitative computation of local differences in ventilation metrics between pre- and post-treatment."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoint of this trial is to perform an extensive evaluation on the effect of RT on the lung parenchyma of lung- and breast cancer patients using ventilation metrics derived using a gas mixture of 30Vol% Xe in 70Vol% O2 as contrast agent combined with DECT.","definition_or_measurement_approach":"Evaluation using ventilation metrics derived from DECT imaging with a 30 Vol% Xe / 70 Vol% O2 contrast gas mixture to assess effects of radiotherapy on lung parenchyma."}

Belgium

Earliest CTIS Part Ii Submission Date

02-10-2025

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

126

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium