NCT03409029

Brief Summary

The standard non-surgical treatment for muscle invasive bladder cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around a third of patients with up to 12% suffering from grade 3-4 toxicity. Effective radiotherapy depends on delivering a curative dose to the target whilst minimising dose to surrounding tissues to reduce toxicities. As an organ that constantly varies in shape and position, achieving this in bladder irradiation is challenging. Cone beam Computed Tomography (CBCT) has allowed visualisation of soft tissue on treatment and hence image-guided treatment and improved accuracy, but the image quality of CBCT is suboptimal for distinguishing soft tissue boundaries. On the other hand, MRI scans produce superior soft tissue definition and visualisation of tumour bed. This would in turn allow for various ways of optimising treatment and potentially improving outcome. There have been a number of studies evaluating pelvic organ motion in bladder cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using CBCT imaging which is often poor quality with limited soft tissue contrast. MRI offers better visualization of the tumour bed and organs at risk (OARs). As a result, the utilisation of MRI in radiotherapy could allow for increased radiation dose to the tumour bed while maintaining minimal dose to surrounding soft tissue. This study will explore the role of MRI imaging in adaptive radiotherapy for bladder cancer with development of a number of theoretical treatment strategies.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

January 10, 2018

Last Update Submit

January 29, 2018

Conditions

Bladder Cancer

Keywords

bladderradiotherapymagnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies

    Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies

    18 months

  • Dose to the Organs At Risk for different adaptive radiotherapy strategies

    Dose to the Organs At Risk for different adaptive radiotherapy strategies

    18 months

Secondary Outcomes (2)

  • Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment cystoscopy.

    18 months

  • Bladder filling using MR sequences and stratification of patients into large or small bladder and tumour bed motion

    18 months

Study Arms (1)

MRI Scan

EXPERIMENTAL

As part of the study patients will undergo 4 MRI scans during radiotherapy treatment. These will take place during the 1st, 2nd, 3rd and 4th week of treatment

Diagnostic Test: MRI Scan

Interventions

MRI ScanDIAGNOSTIC_TEST

Additional imaging using MRI scan

MRI Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of bladder cancer
  • Treatment with primary curative intent
  • Undergoing external beam radiotherapy (+/-chemotherapy)
  • Age over 18 years

You may not qualify if:

  • Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
  • Any contraindications to both Hyoscine Butylbromide (Buscopan)
  • Previous cystectomy
  • Unable to tolerate MRI scans
  • Metastatic disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ananya Choudhury, MA, PhD

    The Christie NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Falk

CONTACT

0044 161 446 8318sally.falk@christie.nhs.uk

Yee Pei Song

CONTACT

0044 161 446 8318yeepei.song@christie.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single site, non-randomised basic science study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Project Manager

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 24, 2018

Study Start

March 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share