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临床试验/NCT04351204
NCT04351204招募中不适用

The MR-Linac Technical Feasibility Protocol For Development of MR-guided Adaptive RadiationTherapy

The Netherlands Cancer Institute2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
technical feasibility

研究概览

简要总结

Radiation therapy is predominantly based on a Computed Tomography (CT) scan obtained during the treatment planning phase. During the course of radiotherapy, however, both the tumor and organs at risk (OAR) are variable in position, shape and size between fractions, and during beam delivery within one treatment fraction. Around the clinical target volume (CTV) a safety margin (Planning Target Volume, PTV) is created to account for these geometric uncertainties to ensure that the tumor receives the prescribed dose.

Direct integration of imaging at the linear accelerator enables daily monitoring of patient positioning, tumor position, and alterations in patient anatomy. Image guided radiotherapy (IGRT) enables the detection and immediate correction of such deviations and increases the precision of delivery.

Adaptive radiotherapy has become an important strategy for serially modifying dose distributions in a manner that can substantially reduce OAR dose and subsequent toxicity, while maintaining adequate target coverage. Current adaptive protocols rely upon a standard CT-based workflow and (cone-beam) CT-based image guidance.

Magnetic Resonance Imaging (MRI) has superior soft-tissue contrast over CT and seems a very promising modality to integrate in the radiation treatment process, facilitating better visualization of the tumor and OAR during treatment.

详细描述

The proposed protocol aims to determine feasibility of multiple new techniques and software for MR-guided adaptive radiation therapy. For each proposed technique feasibility has to be determined individually. A secondary aim is to prospectively collect data from cohorts of patients treated at the MRL and report on acute toxicity.

By including multiple parallel cohorts, the protocol will accelerate the technical development of MR-guided adaptive radiotherapy and the evidence-based introduction of the MRL into clinical practice.

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

入选标准

  • Patient, age ≥ 18 years, treated with radiation therapy on the MRL.
  • WHO performance 0-
  • Ability to understand and the willingness to sign a written informed consent document

排除标准

  • Contra-indications for an MRI examination.
  • Patient is pregnant.
  • Claustrophobia.
  • Patients >140 kg and/or a body width > 60 cm.
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation.

结局指标

主要结局

technical feasibility

时间窗: 4 years

Feasibility of the technical procedure is demonstrated if the technique is successfully applied in 9 out of 10 consecutive patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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