Confocal Laser Endomicroscopy During TransUrethral Resection for Improving BC Diagnosis and Treatment

NCT05273593 | Completed DMC

• 1 other identifier: NL71360.018.19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective monocenter diagnostic accuracy study of Confocal Laser Endomicroscopy (CLE) for Bladder Cancer(BC) to assess two primary objectives:

1. 1.The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy (CLE) compared to histopathology of the resection specimen.
2. 2.The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed (radical vs irradical) in comparison with histopathology of a biopsy of the resection bed.

Conditions

Bladder Cancer; CLE

Keywords

Confocal Laser Endomicroscopy; CLE; Bladder cancer; Diagnosis; Imaging techniques

Outcome Measures

Primary Outcomes (3)

• Diagnostic accuracy of flexible-probe based CLE(pCLE) for the diagnosis of urothelial carcinoma of the bladder (UCB)

  Diagnostic accuracy (sensitivity, specificity, negative predictive value and positive predictive value) of flexible probe based CLE for the diagnosis (low-grade malignant, high-grade malignant) of urothelial carcinoma of the bladder.

  Consensus panel within 12 months of start of study.

• Diagnostic potential of probe based CLE for assessment of surgical radicality after transurethral resection of a bladder tumour (TURBT).

  To investigate the diagnostic potential of CLE for the assessment of the surgical radicality (residual tumor/no residual tumor) after TURBT.

  Consensus panel within 12 months of start of study.

• Diagnostic potential of probe based CLE for assessment of depth of resection after transurethral resection of a bladder tumour (TURBT).

  To investigate the diagnostic potential of CLE for depth of resection (according to the tissue in the resection margin: urothelium, submucosa, m. detrusor or perivesical fatty tissue) after TURBT.

  Consensus panel within 12 months of start of study.

Secondary Outcomes (1)

• Computer aided assessment of pCLE images for diagnosis and grading of UCB

  Within 24 months after starting study

Interventions

Confocal Laser Endomicroscopy (CLE) DEVICE

Administration of fluorescein, intravesically and intravenously. CLE measurements with flexible and rigid probe of papillary bladder tumour and rigid probe-measurement of resection bed.

Eligibility Criteria

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

You may qualify if:

• Display a papillary bladder tumor on cystoscopy.
• \>18 years of age.
• Has given written informed consent.

You may not qualify if:

• Patients with a known allergy to fluorescein.
• Pregnancy or lactating women.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• J. R. Oddens, MD, PhD

  Staff member of Urology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Urology

Model Details: Feasibility study

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 10, 2022
• Study Start: January 6, 2020
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

NL (1)