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临床试验/NCT03402425
NCT03402425Unknown不适用

The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Change of treatment

研究概览

简要总结

To investigate the diagnostic value of 18F-FET PET/MRI instead of MRI alone, children and adolescents with tumor in brain or spinal cord are included and scanned primarily at our hybrid PET/MRI using the amino acid analog 18F-FET. The scans are performed at primary diagnosis, before radiation therapy, before and after operation, when relapse is suspected and three or six months after initiation of chemotherapy.

详细描述

Background. Tumors in the brain and spinal cord are among the most common causes of death and disability by cancer in children and adolescents. MRI is used for primary diagnosis as well as follow-up but is often challenged by tissue changes caused by the treatment. The amino acid analog 18F-FET is used increasingly in adults to delineate tumor and discriminate tumor from treatment effects. A hybrid PET/MRI scanner enables the simultaneous imaging with PET and MRI, which is important in especially the younger children needing anaesthesia to cooperate to the procedure.

Aim The aim of the study is to compare diagnostics using MRI alone with 18F-FET PET/MRI (or sequential MRI and PET) in children and adolescents diagnosed with a central nervous system (CNS) tumor before the age of 18 years. The scans will be performed at primary diagnosis/before operation/biopsy, within 72 hours after operation, planning radiation therapy, evaluation of treatment effect, when relapse is suspected.

Exclusion criteria are MRI contraindications, pregnancy, or a syndrome with increased sensitivity to radiation.

The investigators wish to evaluate which cases and for which tumor types, 18F-FET PET/MRI will increase sensitivity and specificity of diagnosing CNS tumors.

Side effects The side effects are mainly the side effect from the MRI with venous puncture, the MRI contrast leading that can lead to shortlived nausea or headache, fasting for 6 hours and the radioactivity exposure of 4.2 mSv (1,4 times the early background radiation) for each scan procedure. The maximal number of scans in the project is 3, 6 or 10 depending on the diagnosis.

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

盲法说明

The result of the PET scan is masked until a treatment plan for the patient has been decided by the treatment responsible clinicians based on the MRI findings.

入排标准

性别
All
接受健康志愿者

入选标准

  • Suspicion of newly diagnosed CNS tumor, recurrence or radiation therapy planning
  • age <18 years at first CT/MRI suggesting CNS tumor
  • written informed consent from parents (age < 18 years) or the patient (age >18 years)

排除标准

  • contraindications for MRI (e.g. metal implants)
  • pregnancy
  • known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia

研究组 & 干预措施

All included patients

Experimental

A 18F-FET PET scan is performed

干预措施: 18F-FET PET (Diagnostic Test)

结局指标

主要结局

Change of treatment

时间窗: up to 3 months

The treatment plan is changed based on the PET findings

次要结局

  • Sensitivity and specificity(up to 3 months)
  • Recurrence free survival time(at least one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisbeth Marner

MD, PhD, DMSc, Staff Specialist

Rigshospitalet, Denmark

研究点 (2)

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