Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Evaluation of Ultrasound Probe for Use in Bladder Radiotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by University Hospital Birmingham NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dr Anjali Zarkar, University Hospital Birmingham NHS Foundation Trust Identifier:
First received: September 17, 2012
Last updated: September 28, 2012
Last verified: September 2012

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.

Bladder Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Ultrasound Probe for Use in Adaptive Bladder Radiotherapy

Resource links provided by NLM:

Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • Accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement [ Time Frame: 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.

Estimated Enrollment: 5
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)
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers from within the staff of the Radiotherapy, Medical Physics and Oncology departments at the Queen Elizabeth Hospital

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Pre-existing bladder conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01698359

Contact: Gareth Webster, PhD +44 (0) 121 37 1 5056
Contact: anjali Zarkar, FRCR 0121 371 3559

United Kingdom
University hospital Birmingham Not yet recruiting
Birmingham, west Midlands, United Kingdom, B15 2TH
Principal Investigator: Anjali Zarkar, FRCR MD MBBS         
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Principal Investigator: Anjali Zarkar, FRCR UHB
  More Information

Responsible Party: Dr Anjali Zarkar, Consultant Clinical Oncologist, University Hospital Birmingham NHS Foundation Trust Identifier: NCT01698359     History of Changes
Other Study ID Numbers: RRK4571
Study First Received: September 17, 2012
Last Updated: September 28, 2012

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on April 27, 2017