Magnetic Resonance Imaging-guided Online Adaptive Radiotherapy Using a Dedicated MR-simulator and a Cone Beam CT Based Treatment Delivery for Stereotactic Body Radiation Therapy of Pelvic Lymph Node Metastases (MACULA-Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of successfully delivered fractions
研究概览
简要总结
In this study, the investigators want to investigate whether online-adapted radiotherapy using a special magnetic resonance imaging (MRI) simulator and computed tomography (CT)-guided radiation therapy, is feasible and offers advantages for the treatment of pelvic lymph node metastases.
详细描述
MR-guided online adaptive radiotherapy has been implemented recently using MR-linac technology, where MR-imaging is combined with linac technology in hybrid systems. These systems offer MR imaging for online adaptive radiotherapy (RT) within the treatment room and with the patient in treatment position. Despite results regarding technical and clinical feasibility being promising, the high costs of MR-linacs systems and the high demands for staffing resources of MR-linacs are limiting a boarder implementation of this technology. At the Department of Radiation Oncology, University Hospital Zurich, MRI-simulations for RT planning using a dedicated scanner have been performed since 2023. The investigators have developed and implemented an MRI-only RT planning workflow followed by RT delivered at a CBCT-guided, conventional linac. The aim to expand the MRI-only workflow to online adaptive RT. This study will investigate the feasibility of MRI-guided, online adaptive SBRT for pelvic and para-aortic lymph node metastases using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Intra-pelvic and para-aortic lymph node metastases from a histologically confirmed malignancy;
- •Indication for SBRT based on a multidisciplinary tumor board recommendation and / or clinical practice guideline;
- •Intra-pelvic and para-aortic lymph node metastases confirmed by imaging and amenable for SBRT
排除标准
- •Large body size that would not fit the MRI-simulator bore;
- •Contraindications for MRI including but not limited to
- •electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants that are labeled as MR unsafe. Electronic devices labeled as MR safe or MR conditional are not a contraindication;
- •metallic foreign body in the eye or aneurysm clips in the brain;
- •severe claustrophobia;
- •hip prosthesis that are labeled as MR unsafe;
- •More than 5 pelvic lymph node metastasis
- •Previous radiation therapy directly overlapping with SBRT in this study and leading to exceeding tolerance of OARs;
- •History of Crohn's disease, ulcerative colitis
研究组 & 干预措施
MR-guided online adaptive RT using a dedicated MR-simulator and cone-beam CT (CBCT)-based treatment
干预措施: Magnetic resonance Imaging-guided online adaptive radiotherapy (Radiation)
结局指标
主要结局
Rate of successfully delivered fractions
时间窗: during treatment, 1-2 weeks
Feasibility is measured as a successful delivery of an MRI-adapted plan using CBCT image-guidance in another room in 90% of the SBRT fractions.
Rate of successfully delivered fractions
时间窗: during treatment, 1-2 weeks
Feasibility is measured as a successful delivery of an MRI-adapted plan using CBCT image-guidance in another room in 90% of the SBRT fractions.
次要结局
- Average improvement of coverage of planning target volume(During treatment, 1-2 weeks)
- Average improvement of coverage of planning target volume(During treatment, 1-2 weeks)
- Adverse Events(during SBRT, 3 months and 24 months of follow-up)