Bladder CancerNCT05260788
Mapping 3D Bladder
An observational study of Bladder Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Cystoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2022to Mar 2025
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation and intent to treat using external beam radiation therapy.
Who may be able to join
- 18 years of age or older.
- Clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation.
- Intention to treat using external beam radiation therapy as part of standard of care.
- Ability to provide written informed consent to participate in the study.
Who cannot join
- Prior complete or partial radiation therapy to bladder.
- Contraindications to radiation therapy as determined by the treating physician.
- Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Spatially Registered Endoscopy for Mapping Bladder Mucosal Disease Into Radiation Planning Morphologic Imaging
This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. If feasible, this 3D reconstructed shape would be spatially registered to radiological images (CT, MR) that are then used during radiation treatment planning. This analysis would not be used for making any clinical treatment decisions on the patient.
- Conditions
- Bladder Cancer
- Being tested
- Cystoscopy
- 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.
CystoscopyProcedure or surgery
Standard of care cystoscopy procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Video recording of Cystoscopy
To determine the feasibility of using bladder endoscopic video images to reconstruct the three-dimensional shape of the bladder based on computer visions methods that employ feature extraction and triangulation and to map the endoscopy images onto the recreated 3D surface.
Measured: At study completion, up to 2 years
Contouring of 3D bladder rendering
To determine the feasibility of contouring the mucosal disease on the 3D bladder rendering.
Measured: At study completion, up to 2 years
Registering bladder shape
To determine the feasibility of registering the bladder shape to a CT/MR scan of the patient using deformable shape methods.
Measured: At study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Administrative issues.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260788
- Sponsor's protocol ID
- 21-5338
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Spatially Registered Endoscopy for Mapping Bladder Mucosal Disease Into Radiation Planning Morphologic Imaging
- ClinicalTrials.gov ID
- NCT05260788
- Acronym / sponsor ID
- 21-5338
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Administrative issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. If feasible, this 3D reconstructed shape would be spatially registered to radiological images (CT, MR) that are then used during radiation treatment planning. This analysis would not be used for making any clinical treatment decisions on the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation and intent to treat using external beam radiation therapy.
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation.
- Intention to treat using external beam radiation therapy as part of standard of care.
- Ability to provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Prior complete or partial radiation therapy to bladder.
- Contraindications to radiation therapy as determined by the treating physician.
- Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning.
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 |
|---|---|---|
| CystoscopyStandard of care cystoscopy procedure | Procedure or surgery | – |
Primary outcome
Video recording of Cystoscopy
Time frame: At study completion, up to 2 years
To determine the feasibility of using bladder endoscopic video images to reconstruct the three-dimensional shape of the bladder based on computer visions methods that employ feature extraction and triangulation and to map the endoscopy images onto the recreated 3D surface.
Contouring of 3D bladder rendering
Time frame: At study completion, up to 2 years
To determine the feasibility of contouring the mucosal disease on the 3D bladder rendering.
Registering bladder shape
Time frame: At study completion, up to 2 years
To determine the feasibility of registering the bladder shape to a CT/MR scan of the patient using deformable shape methods.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Video recording of Cystoscopy (time frame: At study completion, up to 2 years). The study lists 3 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 14 Apr 2022.