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临床试验/NCT02062372
NCT02062372终止不适用

Spatial Analysis and Validation of Glioblastoma on 7 T MRI

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
The co-localisation of the Gross Tumour Volume (GTV) on 7T MRI and 3T MRI

研究概览

简要总结

Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of different therapeutic modalities including resection, concurrent chemo- and radiotherapy and adjuvant temozolomide. However, survival is still poor and most of these tumours recur within one to two years within the previously irradiated target volume.

The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include microscopic speculated growth. These margins result in a high dose to surrounding healthy appearing brain tissue. Moreover, the short progression-free survival indicates a possible geographical miss. There is a clear need for novel imaging techniques in order to better determine the degree of tumour extent at the time of treatment and to minimize the dose to healthy brain tissue.

The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T) provides an increased ability to detect, quantify and monitor tumour activity and determine post-treatment effects on the normal brain tissue as a result of a higher resolution, greater coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only few investigators have examined the use of UHF MRI in patients with malignant brain tumours. These studies show its potential to assess tumour microvasculature and post-radiation effects such as microhaemorrhages.

This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV) in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively identified when compared to the 3T MRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Supratentorial tumour
  • Suspected GBM on diagnostic MRI
  • Eligible for biopsy
  • Minimum age 18 years or older
  • World Health Organization (WHO) Performance scale ≤2
  • American Society of Anaesthesiologist (ASA) class ≤ 3
  • Understanding of the Dutch language
  • Ability to comply to study procedure

排除标准

  • Recurrent tumour
  • Tumour location deemed unfit for extra biopsies
  • Prior radiotherapy to the skull
  • Prior chemotherapy
  • World Health Organization (WHO) Performance scale ≥ 3
  • American Society of Anaesthesiologist (ASA) class ≥ 3
  • Eligibility for immediate debulking
  • Contra-indications for gadolinium
  • Contra-indications for the MRI

研究组 & 干预措施

Biopsy

Experimental

Subjects will receive a 7 T MRI and one additional biopsy to their standard diagnostic biopsies

干预措施: 7 T MRI (Device)

Biopsy

Experimental

Subjects will receive a 7 T MRI and one additional biopsy to their standard diagnostic biopsies

干预措施: Biopsy (Procedure)

结局指标

主要结局

The co-localisation of the Gross Tumour Volume (GTV) on 7T MRI and 3T MRI

时间窗: Six months after biopsy

The spatial overlap in GTV between 7T MRI and 3T MRI as well as inter- and intra-observer variability will be measured with the Dice Similarity Coefficient (DSC) and the mean of the slice-wise Hausdorff distances.

次要结局

  • The correspondence between glioblastoma cells found in the biopsies and region of interest (ROI) on the 7T MRI scan.(Within a month after biopsy)
  • The co-localisation of the Clinical Target Volume (CTV) on 7T MRI and 3T MRI(Six months after the biopsy)
  • The co-localisation of the organs at risk (OAR) on 7T - and 3T MRI(Six months after biopsy)
  • The correlation between the first tumour recurrence on 3T MRI follow-up images and ROI on the 7T MRI scan(approx. one month after tumour recurrence)
  • The quantification of tumour heterogeneity on 7T MRI and 3T MRI(Six months after biopsy)
  • The visibility of white matter tracts on 7T MRI and 3T MRI(Six months after the biopsy)
  • Tolerability and side effects 3T MRI and 7T MRI scan(After 3T MRI and 7T MRI)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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