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临床试验/NCT02649699
NCT02649699已完成不适用

Quantitative and Multi-Parametric 3D Magnetic Resonance Imaging of Primary Brain Tumors

AHS Cancer Control Alberta2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Comparisons of radiation treatment plans by means of tumor control probabilities calculated from dose-volume histograms

研究概览

简要总结

The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition and processing techniques on primary brain tumor patients. The objectives are to improve image-guided radiation therapy (IGRT) planning (first part of the study) and treatment monitoring (second part).

详细描述

In traditional IGRT the radiation treatment is planned and simulated on computers using x-ray computed tomography (CT) images alone or a combination of CT and MRI. The CT mostly provides information about attenuation of radiation beams needed for the dose simulations because most tumours are more readily identified and contoured with MRI. However, fusion of CT and MR images is prone to error and is a time-consuming process that cannot be automated reliably. Previous research (Stanescu et al.) has shown that the attenuation information can be obtained from MRI which, unlike CT, does not use ionizing radiation to create images. Eliminating the CT scan is therefore possible and beneficial to both the patient, who avoids an additional dose of diagnostic x rays, and to the health care system which saves resources that can be used elsewhere.

Our new MRI acquisition and processing techniques (performed at 3 tesla i.e. 3T) enable:

  1. the extraction of 4 different quantitative parameters (hence "multi-parametric MRI", quantitative MRI or relaxometry) that are normally not accessible in traditional MRI, and
  2. the automatic classification of tissues (e.g. bone, air, adipose, soft tissue, etc.) which is needed for dose computation in IGRT planning

In the first part of the study (dosimetry) these MRI methods will be used to generate a pseudo-CT to replace the traditional CT data. The hypothesis is that dosimetry can be accurately calculated for primary brain cancer patients using the pseudo-CT, thus allowing radiation treatment planning using MRI only. The IGRT treatments planned using qMRI will be compared to those planned conventionally.

The second part of the study (treatment monitoring) aims to evaluate the ability of qMRI techniques to provide clinical information such as distinguishing between progression and pseudo-progression, assessing treatment effectiveness or prognosis. The hypothesis is that qMRI can provide increased sensitivity to biological changes in tumors associated with disease progression over conventional (T1- or T2-weighted) MRI. The reasoning is that by providing quantitative, rather than weighted, images, direct numerical comparisons can be made between images acquired at different time points or at different centres. With traditional MRI, only limited, qualitative comparisons of tumor morphology or relative intensity within the same image can be made. Therefore, 3 or more follow-up MRI scans will also be acquired 3, 6 and 12 months after treatment and at recurrence, transformation, or pseudoprogression to monitor the effectiveness of the treatment.

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

  • At least 18 years of age.
  • Competent to sign informed consent.
  • Diagnosed with primary tumor of the brain.
  • Undergoing IGRT.
  • Willing to participate in initial and follow up scan(s).
  • Can lie supine in the MRI scanner for a period of about 45 minutes.
  • Has signed informed consent.

排除标准

  • Pregnancy.
  • Contraindications to MRI (e.g., pacemakers, magnetic implants, metal in eye, claustrophobia).
  • Has metallic implants in regions of interest (dental braces are okay).

结局指标

主要结局

Comparisons of radiation treatment plans by means of tumor control probabilities calculated from dose-volume histograms

时间窗: 12 months

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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