Conventional anatomical planning radiotherapy
RadiationConventional anatomical planning will be performed
NCT Number: NCT07289646
Stereotactic body radiotherapy (SBRT) has an increasing role in the treatment of both primary and secondary lung tumors. However, lung SBRT remains associated with significant radiation induced lung injury (RILI). Indeed, the reported incidence of symptomatic radiation induced lung injury (grade≥2) in the published literature is up to 20%. A current challenge of lung SBRT is therefore to better preserve lung function and to reduce pulmonary toxicity.
During standard lung SBRT planning, dose constraints are defined on the anatomical lung volume. This planning considers the lung as functionally uniform and does not take into account the variability of regional lung function distribution. Functional lung avoidance is an emerging concept in lung radiotherapy (RT). The technique aims at personalizing RT treatment planning to individuals' lung functional distribution, by sparing functional pulmonary areas while prioritizing delivery of high doses to non-functional regions.
68Ga-MAA lung perfusion PET/CT is a novel imaging modality for regional lung function assessment. As compared with conventional lung scintigraphy, lung perfusion PET/CT is inherently a vastly superior technology for image acquisition (higher sensitivity and spatial resolution, greater access to respiratory gated acquisition). A more accurate lung functional mapping improves the possibility of functional lung avoidance planning for SBRT.
The hypothesis is that functional lung avoidance planning guided by 68Ga-MAA perfusion PET/CT, while delivering an optimal dose to the tumor, will reduce the frequency of RILI in patients treated with lung SBRT.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
CHU Brest, Brest, Finistère, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional anatomical planning will be performed
Functional Lung Avoidance guided by lung perfusion PET/CT imaging
Time frame: At year after baseline
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.
Time frame: Measured at 3, 6, 9, and 12 months after baseline
Quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), with scores ranging from 0 to 100; higher scores indicate better quality of life for the global health status and functional scales, and worse symptoms for the symptom scales.
Time frame: Measured at 3, 6, 9 and 12 months after baseline
Quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC29), with scores ranging from 0 to 100; higher scores indicate worse symptom burden.
Time frame: Measured at 3, 6, 9, and 12 months after baseline
Quality of life as assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, with index values ranging from -0.594 to 1.0, where higher scores indicate better health-related quality of life.
Time frame: Measured at 3, 6, 9, and 12 months after baseline
Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales
Time frame: Measured at 3, 6, 9, and 12 months after baseline
Local tumor control;
Time frame: Measured at 3, 6, 9, and 12 months after baseline
Progression-free survival
Time frame: at 12 months after baseline
Overall survival
Time frame: at 3 months after baseline
Lung perfusion PET/CT imaging
Time frame: at 12 months after baseline
Grade≥2 lung toxicity during the year following lung SBRT
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Acronym: Pegasus 2
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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