Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment

NCT06679920 | Recruiting

• 2 other identifiers: NL83449.018.23ESTAR21207
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to see if a new designed optical coherence tomography catheter can be used in bladder cancer in patients undergoing a transurethral resection of a bladder tumour. The main question it aims to answer is: \- Is the optical coherence tomography catheter feasible in capturing images of bladder tumours and normal bladder wall during a transurethral resection of a bladder tumour? Participants will undergo measurements with a new optical coherence tomography device during the transurethral resection of their bladder tumour(s).

Conditions

Bladder Cancer

Keywords

OCT; Optical Coherence Tomography; Bladder cancer

Outcome Measures

Primary Outcomes (2)

• Procedural feasibility

  The ability to generate images of the normal bladder wall and bladder tumour(s). Feasibility will be achieved if diagnostic images of the tumour and normal bladder are obtained in over 60% of the patients.

  During the TURBT

• Image utilization feasibility

  Feasibility will also be assessed by determining the percentage of images suitable for diagnosis out of the total number obtained. A percentage exceeding 80% will be deemed feasible.

  During the TURBT

Secondary Outcomes (5)

• Duration of the measurements

  During the TURBT

• Concordance tumour stage based on OCT with histopathology

  From TURBT to histopathology result (approximately 4 weeks)

• Concordance between tumour grade based on OCT and histopathology

  From TURBT to histopathology result (approximately 4 weeks)

• Evaluable resection bed OCT images

  During the TURBT

• Concordance OCT and WLC tumour stage and grade

  From TURBT to histopathology result (approximately 4 weeks)

Study Arms (1)

Optical coherence tomography measurements during transurethral resection of a bladder tumour

OTHER

Single arm

Device: Optical coherence tomography

Interventions

Optical coherence tomography DEVICE

Measurement with opctical coherence tomography of tumour and normal bladder tissue during transurethral resection of a bladder tumour (TURBT)

Optical coherence tomography measurements during transurethral resection of a bladder tumour

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years.
• Have at least 1 suspected bladder tumour seen at cystoscopy.
• Have a bladder that is accessible for cystoscopy.
• Be in a physical condition to undergo a TURBT.
• Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation/intervention.

You may not qualify if:

• Pregnant or lactating women.
• The only tumour site is at the bladder neck.
• The tumour(s) is larger than 2 centimetres in diameter.
• \>5 tumours present.
• Solely a suspected flat lesion present.

Sponsors & Collaborators

• Amsterdam UMC: lead

Study Sites (2)

Amsterdam University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

NOT YET RECRUITING

Amsterdam University Medical Center

Amsterdam, 1081HV, Netherlands

RECRUITING

Related Publications (1)

• Remmelink MJ, Nieuwenhuijzen JA, de Bruin DM, Oddens JR. Newly Designed Optical Coherence Tomography Catheter for Optimizing Bladder Cancer Diagnosis and Treatment: Protocol for a Feasibility Study. JMIR Res Protoc. 2025 Dec 2;14:e76644. doi: 10.2196/76644.

  PMID: 41329952 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Tomography, Optical Coherence

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)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Marinka Remmelink, MD

CONTACT

+310204441376; m.j.remmelink@amsterdamumc.nl

Jorg R Oddens, MD, PhD

CONTACT

j.r.oddens@amsterdamumc.nl

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: Prof. dr. H.P. Beerlage

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

NL (2)