跳至主要内容
临床试验/NCT03648619
NCT03648619终止不适用

Evaluation of an Innovative Automatized "Semi-Whole-Body"-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging

Kantonsspital Baden2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
2
主要终点
to compare lesion detectability between wb-MRI and the gold standard PET/CT

研究概览

简要总结

The aims of this study are

  • to evaluate the image quality and robustness of a whole-body MRI protocol by using an innovative partially automatic algorithm (DOT engine), that automatically optimizes protocol parameters depending on body region (e.g. thorax versus abdomen)
  • to compare lesion detectability between wb-MRI and the gold standard positron emission tomography (PET)/CT
  • to compare patient comfort between PET/CT and wb-MRI using a dedicated questionnaire
  • to compare duration of image acquisition with regards to cost-effectiveness

详细描述

Whole-body imaging becomes increasingly important in oncologic patients not only for primary cancer staging, but also for assessment of response to therapy. So far, PET/CT is a key method to assess cancer-related changes of metabolism in tumors, which is crucial for response evaluation and to differentiate between benign and malignant lesions. Limitations of PET/CT include the assessment of sclerotic bone metastasis, which often do not show increased tracer uptake. Certain organ metastasis (especially in brain and liver) are also barely detectable due to physiologically increased uptake. Moreover, both CT and administration of radioactive tracer are associated with radiation exposure for patients. Whole-body MRI (wb-MRI) including functional techniques (e.g. Diffusion-weighted Imaging (DWI) to evaluate cell density) enables a functional staging and therapy assessment without use of ionizing radiation. Advantages to assess sclerotic bone lesions and organ metastases have been confirmed in recent literature. Limitations of MRI include detection of lesions in organs with high susceptibility and motion like the thorax.

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

  • Clinically indicated PET/CT for cancer staging or response assess-ment in patients with histopathologically confirmed solid tumors (e.g.prostate, breast, gastrointestinal, testicles)
  • MRI can be scheduled within 1 week to PET/CT exam

排除标准

  • general MRI contraindications (devices (e.g. certain pacemakers), pregnancy, claustrophobia)
  • severely reduced general condition
  • impaired renal function

结局指标

主要结局

to compare lesion detectability between wb-MRI and the gold standard PET/CT

时间窗: 30 minutes duration of study-related MRI protocol

- Primary outcome will be the organ based malignant lesion detectability (Thorax, Abdomen). This will be quantified as a dichotomous variable (present/absent) for MRI and PET/CT. Outcome will be based on two board certified radiologists. In case of disagreement, consensus will be taken. Results will be obtained in a single reading after inclusion of 50 patients. Readers will be blinded to clinical patient data and results of PET/CT.

次要结局

  • Secondary outcome will be the number of lesions(5 minutes assessment of a dedicated questionnaire to assess patient comfort)

研究者

发起方
Kantonsspital Baden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Hausmann

Head of Abdominal and Oncologic Imaging

Kantonsspital Baden

研究点 (2)

Loading locations...

相似试验

Automatized "Semi-Whole-Body"-MRI Protocol for... | 临床试验