Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy

Обзор

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.

Вмешательства

• Лучевая терапия Conventional anatomical planning radiotherapy
  Conventional anatomical planning will be performed
• Лучевая терапия Functional Lung avoidance planning
  Functional Lung Avoidance guided by lung perfusion PET/CT imaging

Первичные конечные точки

• To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT. [Срок оценки: At year after baseline]

Вторичные конечные точки (7)

• quality of life assessment [Срок оценки: Measured at 3, 6, 9, and 12 months after baseline]
• quality of life assessment [Срок оценки: Measured at 3, 6, 9 and 12 months after baseline]
• quality of life assessment [Срок оценки: Measured at 3, 6, 9, and 12 months after baseline]
• Grade 3 or higher RILI [Срок оценки: Measured at 3, 6, 9, and 12 months after baseline]
• Local tumor control; [Срок оценки: Measured at 3, 6, 9, and 12 months after baseline]
• Progression-free survival; [Срок оценки: Measured at 3, 6, 9, and 12 months after baseline]
• Overall survival. [Срок оценки: at 12 months after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Inability to give informed consent
• Patientsunder guardianship or curatorship
• Pregnant or breastfeeding women.
• Contraindications to the radiolabeled product infused for lung perfusion PET/CT.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• CHU Brest — Brest
• Centre de Lutte Contre le Cancer Leon Bérard Lyon — Lyon

Идентификаторы

NCT: NCT07289646 · 29BRC23.0220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗