Gallium (68Ga); Human albumin as macroaggregates for Primary lung cancer|Pulmonary metastases

Inclusion criteria

• {"criterion_text":"- Patients aged > 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study"}

Exclusion criteria

• {"criterion_text":"- inability to give informed consent"}
• {"criterion_text":"- patients under guardianship or curatorship"}
• {"criterion_text":"- pregnant or breastfeeding women"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the occurrence of symptomatic RILI (grade≥2 lung toxicity as assessed using the CTCAE 5.0) during the year following lung SBRT. This evaluation will be performed by a medical oncologist blinded from the allocated arm.","definition_or_measurement_approach":"Occurrence of symptomatic radiation-induced lung injury (RILI) defined as grade ≥2 lung toxicity assessed using CTCAE v5.0 during the year following lung SBRT; evaluation performed by a medical oncologist blinded to allocated arm."}

Secondary endpoints

• {"endpoint_text":"- Quality of life as assessed by the EORTC QLQ-C30,EORTC QLQ-LC29 and EQ-5D-5L questionnaires at 3, 6, 9 and 12 months.","definition_or_measurement_approach":"Quality of life assessed by EORTC QLQ-C30, EORTC QLQ-LC29 and EQ-5D-5L at months 3, 6, 9 and 12."}
• {"endpoint_text":"- Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales at 3, 6, 9 and 12 months.","definition_or_measurement_approach":"Lung toxicity assessed with CTCAE v5.0, RTOG and LENT-SOMA scales at months 3, 6, 9 and 12."}
• {"endpoint_text":"- Local tumor control.","definition_or_measurement_approach":"Local tumor control assessed per imaging/clinical follow-up (not further defined in available text)."}
• {"endpoint_text":"- Progression-free survival at 3, 6, 9 and 12 months.","definition_or_measurement_approach":"Progression-free survival assessed at months 3, 6, 9 and 12 (time to progression or death)."}
• {"endpoint_text":"Overall survival at 12 months.","definition_or_measurement_approach":"Overall survival measured at 12 months (time to death from any cause)."}
• {"endpoint_text":"Grade 2 or higher lung toxicity as defined for the primary endpoint.","definition_or_measurement_approach":"Grade ≥2 lung toxicity using CTCAE v5.0 per the primary endpoint definition."}
• {"endpoint_text":"Lung perfusion PET/CT imaging at 3 months.","definition_or_measurement_approach":"Lung perfusion PET/CT imaging performed at 3 months to assess perfusion changes."}
• {"endpoint_text":"To assess the predictive value of the doses delivered to lung functional volumes as compared to the anatomical lung volume on lung perfusion PET/CT imaging at 3 months.","definition_or_measurement_approach":"Evaluation of predictive value of dose to functional lung volumes vs anatomical lung volume on 3-month lung perfusion PET/CT imaging."}
• {"endpoint_text":"To assess the predictive value of the decrease of lung perfusion at 3 months on long term lung toxicity at 12 months.","definition_or_measurement_approach":"Assessment of whether decrease in lung perfusion at 3 months predicts long-term lung toxicity at 12 months."}

France

Earliest CTIS Part Ii Submission Date

04-08-2025

Latest Decision Or Authorization Date

07-10-2025

Processing Time Days

64

Number Of Sites

2

Number Of Participants

418

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France