Bladder CancerNCT03409029
A Study Using MRI To Assess Bladder Motion During Radiotherapy
A study testing MRI Scan in people with Bladder Cancer, run by The Christie NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- MRI Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of bladder cancer
- Treatment with primary curative intent
- Undergoing external beam radiotherapy (+/-chemotherapy)
- Age over 18 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study Using Magnetic Resonance Imaging (MRI) to Assess Bladder Motion During Radiotherapy Treatment.
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.
Read more
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.
Read the detailed description
Patients will undergo standard treatment during the study with four weeks of external beam radiotherapy (20 fractions). They will be treated with weekly Gemcitabine (100mg/m2) or daily Nicotinamide (60mg/kg)/Carbogen (2% carbon dioxide, 98% oxygen at 15 litres per minute) if clinically appropriate.
As part of standard treatment patients will have a staging CT scan at diagnosis and a radiotherapy planning CT. Cone beam imaging will also be performed. Response will be assessed as standard with cystoscopy at 3 months and CT scan at 12 months.
As part of the study patients will undergo 4 additional MRI scans. These will take place in the 1st, 2nd, 3rd and 4th weeks of treatment. These MRI scans will include anatomical images - with full and empty bladder as well as cine data (with a scan every minute for 10 minutes) to assess intra fraction motion. They will also include a diffusion weighted imaging (DWI) sequence, which will be used to assess if early prediction of response is possible. The frequency of cone beam imaging will be increased from 6 scans (minimum) as standard of care to 20 scans to allow for daily imaging.
The 1st MRI scan will be contoured to outline the tumour bed, clinical target volumes (CTVs) and OARs. A variety of planning strategies will be developed including standard planning target volume (PTV) margins, a plan of the day (POTD) approach, a POTD+ as well as an online adaptation model. These models will be used to assess coverage of CTV and PTV, and the feasibility of increasing radiation dose to the tumour bed, as well as dose to OARs using the scans obtained during the radiotherapy treatment. The practicality of each approach will also be assessed. Inter and intra fraction organ and tumour bed motion will also be analysed in order to develop patient specific models.
- Conditions
- Bladder Cancer
- Being tested
- MRI Scan
- Keywords
- bladder, radiotherapy, magnetic resonance imaging
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanDiagnostic test
Additional imaging using MRI scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies
Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies
Measured: 18 months
Dose to the Organs At Risk for different adaptive radiotherapy strategies
Dose to the Organs At Risk for different adaptive radiotherapy strategies
Measured: 18 months
Secondary outcomes (2)
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment cystoscopy.
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment cystoscopy.
Measured: 18 months
Bladder filling using MR sequences and stratification of patients into large or small bladder and tumour bed motion
Bladder filling using MR sequences and stratification of patients into large or small bladder and tumour bed motion
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study startMar 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single site, non-randomised basic science study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Falk, The Christie NHS Foundation Trust
- Investigators
- Ananya Choudhury, MA, PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409029
- Sponsor's protocol ID
- 17_RADIO_130
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Magnetic Resonance Imaging (MRI) to Assess Bladder Motion During Radiotherapy Treatment.
- ClinicalTrials.gov ID
- NCT03409029
- Acronym / sponsor ID
- 17_RADIO_130
- Conditions
- Bladder Cancer
- Keywords
- bladder, radiotherapy, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will undergo standard treatment during the study with four weeks of external beam radiotherapy (20 fractions). They will be treated with weekly Gemcitabine (100mg/m2) or daily Nicotinamide (60mg/kg)/Carbogen (2% carbon dioxide, 98% oxygen at 15 litres per minute) if clinically appropriate.
As part of standard treatment patients will have a staging CT scan at diagnosis and a radiotherapy planning CT. Cone beam imaging will also be performed. Response will be assessed as standard with cystoscopy at 3 months and CT scan at 12 months.
As part of the study patients will undergo 4 additional MRI scans. These will take place in the 1st, 2nd, 3rd and 4th weeks of treatment. These MRI scans will include anatomical images - with full and empty bladder as well as cine data (with a scan every minute for 10 minutes) to assess intra fraction motion. They will also include a diffusion weighted imaging (DWI) sequence, which will be used to assess if early prediction of response is possible. The frequency of cone beam imaging will be increased from 6 scans (minimum) as standard of care to 20 scans to allow for daily imaging.
The 1st MRI scan will be contoured to outline the tumour bed, clinical target volumes (CTVs) and OARs. A variety of planning strategies will be developed including standard planning target volume (PTV) margins, a plan of the day (POTD) approach, a POTD+ as well as an online adaptation model. These models will be used to assess coverage of CTV and PTV, and the feasibility of increasing radiation dose to the tumour bed, as well as dose to OARs using the scans obtained during the radiotherapy treatment. The practicality of each approach will also be assessed. Inter and intra fraction organ and tumour bed motion will also be analysed in order to develop patient specific models.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single site, non-randomised basic science study
| Arm | Type | Receives |
|---|---|---|
| MRI Scan | Experimental | Diagnostic Test: MRI ScanAs 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of bladder cancer
- Treatment with primary curative intent
- Undergoing external beam radiotherapy (+/-chemotherapy)
- Age over 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ScanAdditional imaging using MRI scan | Diagnostic test | MRI Scan |
Primary outcome
Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies
Time frame: 18 months
Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies
Dose to the Organs At Risk for different adaptive radiotherapy strategies
Time frame: 18 months
Dose to the Organs At Risk for different adaptive radiotherapy strategies
2 secondary outcomes
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment cystoscopy.
Time frame: 18 months
Bladder filling using MR sequences and stratification of patients into large or small bladder and tumour bed motion
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
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Performance, Feasibility, and Safety Study for a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours: First-In-Human Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ananya Choudhury, MA, PhD principal investigator
The Christie NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan in people with Bladder Cancer, run by The Christie NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Falk (0044 161 446 8318, sally.falk@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coverage of the Clinical Target Volume for different adaptive radiotherapy strategies (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.