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临床试验/NCT05553899
NCT05553899招募中不适用

Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study

Sheffield Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5
试验地点
2
主要终点
Feasibility of recruitment

研究概览

简要总结

This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in children in our institution.

详细描述

Brain tumours are the most common solid tumours and the leading cause of death from cancer in children. A particular challenge in their management is detection of recurrent, residual or progressive tumour after initial treatment. This is typically detected on conventional MR surveillance scans. However, it is well documented that post-therapeutic changes can occur on MRI which may not represent disease, particularly after radiotherapy. Erroneously interpreting treatment-related changes as tumor progression may lead to the cessation of an effective treatment or the overestimation of the efficacy of a subsequent treatment. This is particularly important when assessing novel therapies in the context of early-phase clinical trials. A more accurate, non-invasive method of monitoring children after treatment for brain tumours could therefore enhance clinical management and may also lead to a more accurate assessment of novel therapies.

Hybrid Positron emission tomography-magnetic resonance imaging (PET/MRI) combines the high contrast and morphological resolution of MRI with the metabolic and physiological resolution from an intergrated PET scan. A variety of PET radiopharmaceutical tracers have been employed but 18F-fluodeoxyglucose (18F-FDG) has evolved over the last two decades to become the most important clinically. Increased glucose metabolism indicated by an increased FDG uptake is commonly seen in proliferating tumors due to the increased glucose transporter expression and the enzyme hexokinase, converting FDG to a phosphorylated product.

FDG-PET/CT has been demonstrated to have use for the differentiation of residual or recurrent tumours from post-therapeutic radiotherapy changes in adults 3-5 but its value in children is largely limited to case reports or small case series. The value of PET/MRI in paediatric in paediatric brain tumours is even less certain but in a series of 85 patients it was found to have a significant impact on management in the majority of cases. The accuracy of FDG PET in tumor surveillance may be higher than what has been historically reported because of improved spatial localization with concurrent use of MRI rather than CT.

This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in our institution. These tumours have the highest uptake of 18F-FDG and PET-MRI is therefore more likely to add diagnostic accuracy during their follow-up.

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
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Have a presumptive or histologically confirmed diagnosis of a malignant brain tumour requiring treatment
  • Diagnostic uncertainty about tumour recurrence post-treatment based on conventional MR imaging in the opinion of the MDT
  • Have a life expectancy of at least three months
  • Able to comply with an MRI scan without a general anaesthetic

排除标准

  • Unable to comply with an MRI scan without a general anaesthetic
  • Diabetes or other causes of hyperglycaemia
  • Pregnancy
  • Patient body habitus above scanner dimensions
  • Standard contra-indication to MRI (eg. pacemaker, non-compatible metallic implants, altered renal function)

研究组 & 干预措施

Diagnostic (PET-MRI)

Experimental

Patients will undergo PET-MRI

干预措施: PET-MRI (Radiation)

结局指标

主要结局

Feasibility of recruitment

时间窗: 1 year

Explore whether it is possible to recruit and scan children for post-treatment surveillance of brain tumours using PET-MRI in Sheffield in our centre

Determine number of patients able to recruited for study in one year

时间窗: 1 year

Determine feasibility of recruitment for study by measuring the number of patients able to recruited for study in one year

次要结局

  • Acceptability(1 year)
  • Accuracy(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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