跳至主要内容
临床试验/NCT01698359
NCT01698359Unknown不适用

Evaluation of Ultrasound Probe for Use in Adaptive Bladder Radiotherapy

University Hospital Birmingham NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5
试验地点
1
主要终点
Accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement

研究概览

简要总结

Muscle-invasive bladder cancer affects over 3,000 new patients in the UK each year and radiotherapy comprises a key part of the treatment pathway for many of them. Bladder radiotherapy in the UK involves delivery of radiation to the entire bladder volume and aims to deliver a high dose to the bladder while sparing nearby healthy organs (e.g. the bowel). Unfortunately, large variations in bladder shape and volume are observed throughout treatment that compromise the probability of a positive outcome for the patient, either by increasing the risk of side-effects or by reducing the likelihood of adequately treating the disease.

In recent years, the implementation of 'adaptive' bladder radiotherapy strategies has increased. These techniques allow modification of the treatment based on the observed variations in bladder shape and volume. However, these strategies often rely on daily X-ray imaging of the patient prior to treatment, which is time-consuming and associated with a small risk of inducing a cancer in the patient.

This study will evaluate the potential of a commercially available ultrasound probe for use as an alternative to X-ray scanning during treatment for these patients. The study will also aim to compare the likelihood of reducing side-effects and successfully treating the disease for the different adaptive strategies that are used around the world.

详细描述

All experiments and data analysis will be performed in the Magnetic Resonance Imaging (MRI) and Radiotherapy departments respectively, at the Queen Elizabeth Hospital.

Five volunteers will be recruited to this study. They will each be required to follow a documented drinking protocol prior to each of three scan sessions. The drinking protocol is specific to this study and will not be intended for use with patients. To address the primary endpoint of the study (i.e. the precision of the ultrasound probe for measurement of bladder volume), measurement of a wide range of bladder volumes is required. In order to address this aim while making efficient use of the limited available MRI scanner time, the drinking protocol has been designed such that the volunteer will begin each scan session with an empty bladder and finish it with a full bladder. To this end, each volunteer will be required to void their bladder upon arrival and then consume 500ml of water immediately prior to the start of the scan session.

Each volunteer will then be positioned on the scanner couch according to the same protocol used for patients and alternate MRI and ultrasound scans will then be acquired. Given the time required for each scan it is anticipated that five MRI scans and fifteen ultrasound scans (three scans at a time to reduce the noise on the results, i.e. ultimately giving five ultrasound bladder volume measurements) will be acquired in each session. Each volunteer will be asked to attend for three sessions over the course of a number of weeks so that the repeatability of bladder filling patterns can be determined.

Data processing and analysis

The volume measurements from the ultrasound probe will be recorded and each of the MRI images will be exported to the Radiotherapy department where the bladder volume will be determined. The precise timings of all scan acquisitions will be recorded during the imaging session. Bladder volumes measured by the ultrasound probe, which can be read instantly, will be recorded during the session. To evaluate the primary endpoint, the precision and accuracy of the ultrasound probe will be quantified by comparing the measured values to those expected from the MRI volumes. Each volume measurement from the MRI scans will be checked by a second observer to minimise any associated researcher error.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • Pre-existing bladder conditions

结局指标

主要结局

Accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement

时间窗: Three weeks

The principal aim of this study is to quantify the accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement. To do this, each of the five volunteers will have 5 repeat measurements of each imaging modality (ultrasound and MRI) within each 45 minute scan session as the bladder volume increases in response to the specified drinking protocol. Each volunteer will undergo three scan sessions over three weeks. Study participants will not receive follow-up. An accuracy of +/-10% would be considered sufficient to inform future studies.

次要结局

未报告次要终点

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anjali Zarkar

Consultant Clinical Oncologist

University Hospital Birmingham NHS Foundation Trust

研究点 (1)

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