Bladder CancerNCT00913536
Cone Beam Computed Tomography (CT) Bladder
A study testing Using Cone beam CT in patients with Bladder Cancer in people with Bladder Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study is designed to investigate whether daily images of the pelvis and bladder using a device called a cone beam CT scanner will help to increase the accuracy of radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. 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?
- Using Cone beam CT in patients with Bladder Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to 11 Oct 2018
- 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
- Diagnosis of carcinoma of the bladder
- Patients undergoing radical external beam radiotherapy
- Age >18 years
- ECOG performance status 0-1
- Informed consent
Who cannot join
- Inflammatory bowel disease or collagen vascular disease
- Patients undergoing palliative radiotherapy to the bladder
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Cone-Beam Computed Tomography in Image-Guided Radiotherapy for Patients With Bladder Cancer
This study is designed to investigate whether daily images of the pelvis and bladder using a device called a cone beam CT scanner will help to increase the accuracy of radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. The results of the study may allow patients in the future who are undergoing radiotherapy treatment for bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of radiation delivered to the tumour while keeping doses to the surrounding normal tissues as low as possible. This may allow eradication of the cancer while minimizing side effects of treatment.
This study consists of two phases: Phase A and Phase B. In Phase A, images were collected and analyzed and it was confirmed that it was useful to use the cone beam machine for daily Cone Beam CT Bladder (Phase B)treatment adjustments. In phase B, we hope to be able to use cone beam CT scans to more accurately direct the radiotherapy treatments on a daily basis.
Read the detailed description
Cone beam computed tomography (CT) is new technology that allows the acquisition of 3-dimensional cross-sectional imaging while the patient is positioned on a linear accelerator couch. Cone beam CT also provides 3D soft tissue volumetric data and therefore important information on daily interfraction movement and deformation of normal critical structures within the pelvis. Visualization of the tumor using this technology may also be enhanced by the additional placement of fiducial markers around the tumor bed to ensure even more accurate targeting. The aim of this study is to assess the feasibility of daily cone beam CT for image guidance in patients receiving radiation therapy (RT) for bladder cancer as well document changes in size and location of the bladder and rectum during an entire course of RT. This will enable us to explore techniques for radiation therapy based on normal tissue avoidance models to reduce treatment toxicity and potentially dose escalation in the future.
- Conditions
- Bladder Cancer
- Being tested
- Using Cone beam CT in patients with Bladder Cancer
- Keywords
- Bladder Cancer, Cone Beam CT, On-line image guidance, Radiation therapy in bladder cancer patients
- 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.
Using Cone beam CT in patients with Bladder CancerOther
Using cone beam CT scanner will help to increase the accuracy of your radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit.
| Study group | Role | What they receive |
|---|---|---|
| Cone beam CT in Bladder Cancer | Experimental | Not described Receives: Other: Using Cone beam CT in patients with Bladder Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving radiation therapy for bladder cancer.
Measured: 5 years
Secondary outcomes (1)
Measure interfraction,intrafraction & deformity of bladder;determine adequacy of present margins; report bladder volume changes during treatment; evaluate use of fiducial markers plus CBCT for on-line image guidance & transabdominal ultrasound system.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionSep 2018
- Study completion11 Oct 2018
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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Peter Chung, MB ChB, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913536
- Sponsor's protocol ID
- UHN REB 05-0620-CE
- Status last verified
- Apr 2019
- First submitted
- 2 Jun 2009
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone-Beam Computed Tomography in Image-Guided Radiotherapy for Patients With Bladder Cancer
- ClinicalTrials.gov ID
- NCT00913536
- Acronym / sponsor ID
- UHN REB 05-0620-CE
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Cone Beam CT, On-line image guidance, Radiation therapy in bladder cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Nov 2005 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 4 Jun 2009 (estimated)
- 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.
This study is designed to investigate whether daily images of the pelvis and bladder using a device called a cone beam CT scanner will help to increase the accuracy of radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. The results of the study may allow patients in the future who are undergoing radiotherapy treatment for bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of radiation delivered to the tumour while keeping doses to the surrounding normal tissues as low as possible. This may allow eradication of the cancer while minimizing side effects of treatment.
This study consists of two phases: Phase A and Phase B. In Phase A, images were collected and analyzed and it was confirmed that it was useful to use the cone beam machine for daily Cone Beam CT Bladder (Phase B)treatment adjustments. In phase B, we hope to be able to use cone beam CT scans to more accurately direct the radiotherapy treatments on a daily basis.
Detailed description
Cone beam computed tomography (CT) is new technology that allows the acquisition of 3-dimensional cross-sectional imaging while the patient is positioned on a linear accelerator couch. Cone beam CT also provides 3D soft tissue volumetric data and therefore important information on daily interfraction movement and deformation of normal critical structures within the pelvis. Visualization of the tumor using this technology may also be enhanced by the additional placement of fiducial markers around the tumor bed to ensure even more accurate targeting. The aim of this study is to assess the feasibility of daily cone beam CT for image guidance in patients receiving radiation therapy (RT) for bladder cancer as well document changes in size and location of the bladder and rectum during an entire course of RT. This will enable us to explore techniques for radiation therapy based on normal tissue avoidance models to reduce treatment toxicity and potentially dose escalation in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cone beam CT in Bladder Cancer | Experimental | Other: Using Cone beam CT in patients with Bladder Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of carcinoma of the bladder
- Patients undergoing radical external beam radiotherapy
- Age >18 years
- ECOG performance status 0-1
- Informed consent
Key exclusion criteria (2 listed)
- Inflammatory bowel disease or collagen vascular disease
- Patients undergoing palliative radiotherapy to the bladder
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 |
|---|---|---|
| Using Cone beam CT in patients with Bladder CancerUsing cone beam CT scanner will help to increase the accuracy of your radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. | Other | Cone beam CT in Bladder Cancer |
Primary outcome
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving radiation therapy for bladder cancer.
Time frame: 5 years
1 secondary outcome
Measure interfraction,intrafraction & deformity of bladder;determine adequacy of present margins; report bladder volume changes during treatment; evaluate use of fiducial markers plus CBCT for on-line image guidance & transabdominal ultrasound system.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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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.
Peter Chung, MB ChB principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Cone beam CT in patients with Bladder Cancer in people with Bladder Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving radiation therapy for bladder cancer. (time frame: 5 years). 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 26 Apr 2019.