Imperial Bladder 1 - Fluorescence COnfocal Microscopy for raPid evaluation of detrusor muscle at primary transurethraL rsEctTion of bladdEr tumours (IB1-LaserCOMPLETE)

A prospective feasibility study to assess ex vivo real-time analysis of detrusor muscle status at time of primary transurethral resection of bladder tumour (TURBT) using fluorescence confocal microscopy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16114765

Enrollment

Registered

2024-08-20

Start date

2024-07-15

Completion date

Unknown

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer Cancer

Interventions

Bladder cancer specimens from subjects undergoing transurethral resection of bladder tumour (TURBT) operation will be stained with a fluorescent dye (Histolog Dip) and then be scanned on a digital flu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing initial or first transurethral resection of bladder tumour (TURBT) for suspected bladder cancer

Exclusion criteria

Exclusion criteria: 1. Radiological or clinical suspicion of muscle-invasive bladder cancer (cT2-T4) 2. Prior diagnosis of NMIBC or MIBC on prior resection 3. Patients who do not consent for ex vivo tissue research through Imperial College Healthcare Tissue Bank (ICHTB) 4. Patients enrolled in concurrent clinical trials requiring ex vivo tissue for research

Design outcomes

Primary

Measure	Time frame
The feasibility of using digital fluorescence confocal microscopy to identify the presence/absence of detrusor muscle in primary transurethral resection of bladder tumour (TURBT) specimens measured by a pathologist who will determine the accuracy at one timepoint	—

Secondary

Measure	Time frame
1. Establish a standard operating procedure for scanning fresh bladder tissue from primary TURBTs using the Histolog FCM machine at one timepoint 2. Agreement of digital FCM with the pathology report for detrusor presence on a specimen at a patient level. Sensitivity, specificity, positive and negative predictive value of digital FCM for detection of detrusor muscle with traditional H&E histopathology as the reference standard, on a per-patient basis at one timepoint 2. Agreement between readers measured by: a) two individual histopathologists; and, by b) a histopathologist versus an operating urological surgeon (Cohen’s kappa coefficient) at one timepoint	—

Measure

Time frame

1. Establish a standard operating procedure for scanning fresh bladder tissue from primary TURBTs using the Histolog FCM machine at one timepoint 2. Agreement of digital FCM with the pathology report for detrusor presence on a specimen at a patient level. Sensitivity, specificity, positive and negative predictive value of digital FCM for detection of detrusor muscle with traditional H&E histopathology as the reference standard, on a per-patient basis at one timepoint 2. Agreement between readers measured by: a) two individual histopathologists; and, by b) a histopathologist versus an operating urological surgeon (Cohen’s kappa coefficient) at one timepoint

—

Countries

England, United Kingdom

Contacts

Public ContactMartin Connor

m.connor@imperial.ac.uk+44 (0)20 3313 1000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026