Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patients with a dose reduction to the functional lung (estimated during functional planning).
研究概览
简要总结
This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).
详细描述
Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.
The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.
Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.
The treatment planning will be carried out in 2 stages:
- First, an anatomical planning will be carried out, blinded to the PET results.
- Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Insured patient
- •Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion
排除标准
- •Unable/unwilling to give informed consent
- •Pregnancy / breast-feeding patient
- •Patient under guardianship or curatorship
- •Patient with contraindication to the administration of macroaggregates of human albumin
研究组 & 干预措施
Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification
All patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including:
- The standard functional assessment recommended before performing an SBRT.
- A perfusion PET/CT scan
The treatment planning will be carried out in 2 stages:
- First, an anatomical planning will be carried out, blinded to the PET results.
- Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by pulmonary PET, will then be carried out.
A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months
干预措施: Pre-therapeutic imaging test (Drug)
结局指标
主要结局
Patients with a dose reduction to the functional lung (estimated during functional planning).
时间窗: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning). A reduction in the dose to the functional lung will be defined by: * A decrease of at least 5% in functional lung volume included in V20Gy. or * A decrease of at least 5% in total relative lung function included in the V20G.
次要结局
- Pulmonary toxicity at 3 months(At 3 months after SBRT( stereotactic body radiation therapy))
- Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning(Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA)
- Pulmonary toxicity at 6 months(At 6 months after SBRT (stereotactic body radiation therapy))
- Dyspnea at 3 months(At 3 months after SBRT (stereotactic body radiation therapy))
- Dyspnea at 6 months(At 6 months after SBRT (stereotactic body radiation therapy))
- Dyspnea at 9 months(At 9 months after SBRT (stereotactic body radiation therapy))
- Pulmonary toxicity at 9 months(At 9 months after SBRT (stereotactic body radiation therapy))
- Pulmonary toxicity at 12 months(At 12 months after SBRT (stereotactic body radiation therapy))
- Dyspnea at Day 0 (inclusion)(Baseline, Day 0)
- Dyspnea at 12 months(At 12 months after SBRT (stereotactic body radiation therapy))