Mapping 3D Bladder

NCT05260788 | Withdrawn

• 1 other identifier: 21-5338
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Cystoscopy PROCEDURE

Standard of care cystoscopy procedure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 2, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CA (1)