Evaluation of Ultrasound Probe for Use in Bladder Radiotherapy

NCT01698359 | Unknown

• 1 other identifier: RRK4571
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Three weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Healthy volunteers

You may not qualify if:

• Pre-existing bladder conditions

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

University hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Anjali Zarkar, FRCR

  UHB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gareth Webster, PhD

CONTACT

+44 (0) 121 37 1 5056; Gareth.Webster@uhb.nhs.uk

anjali Zarkar, FRCR

CONTACT

0121 371 3559; anjali.zarkar@uhb.nhs.uk

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Oncologist

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: October 3, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 3, 2012

Record last verified: 2012-09

Locations

GB (1)