Mapping 3D Bladder

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Cystoscopy

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At study completion, up to 2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 21-5338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No