Evaluation of Ultrasound Probe for Use in Bladder Radiotherapy
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Evaluation of Ultrasound Probe for Use in Adaptive Bladder Radiotherapy|
- Accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement [ Time Frame: Three weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698359
|Contact: Gareth Webster, PhD||+44 (0) 121 37 1 5056||Gareth.Webster@uhb.nhs.uk|
|Contact: anjali Zarkar, FRCR||0121 371 firstname.lastname@example.org|
|University hospital Birmingham||Not yet recruiting|
|Birmingham, west Midlands, United Kingdom, B15 2TH|
|Principal Investigator: Anjali Zarkar, FRCR MD MBBS|
|Principal Investigator:||Anjali Zarkar, FRCR||UHB|