Imperial Bladder 1 - Fluorescence COnfocal Microscopy for raPid evaluation of detrusor muscle at primary transurethraL rsEctTion of bladdEr tumours (IB1-LaserCOMPLETE)
| ISRCTN | ISRCTN16114765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16114765 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | ICHTB HTA licence: 12275 |
| Sponsor | Imperial College Healthcare NHS Trust |
| Funder | Imperial College London |
- Submission date
- 04/07/2024
- Registration date
- 20/08/2024
- Last edited
- 26/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bladder cancer is the seventh most commonly diagnosed cancer and it is 3 to 4 times more common in men than in women. Bladder cancer is first diagnosed by tissue obtained from a transurethral resection of bladder tumour (TURBT) operation. This involves passing a telescope into the bladder along the urethra (water pipe) and removing bladder tumours (growths) using diathermy (electrical current) or laser energy. In 7 in every 10 patients diagnosed with bladder cancer, the cancer is present in the “superficial” layer of the bladder and does not grow deeper into the bladder muscle layer. Treatments for this form of superficial cancer such as bladder installations of chemotherapy or immunotherapy have been effective in reducing the chance of the bladder cancer recurring or progressing over time. Therefore, a key determinant of the correct treatment allocation following this operation is whether muscle was obtained to allow a pathologist to report the correct depth of cancer invasion. Unfortunately, performing this operation can be challenging and in up to 30% of patients there will be no muscle present in the tissue obtained to make an accurate assessment. The knowledge of this will become available 1-2 weeks following the operation. In most patients, the treating urologist will ask for the operation to be repeated to obtain this muscle sample. This has a significant impact on patient's health, quality of life, and a large financial burden on our healthcare service. This study proposes the use of a novel scanner known as “fluorescence confocal microscopy” that could scan and report acquired bladder tissue in the operating theatre “live” to determine if a muscle is present, providing immediate feedback to the operating surgeon. This technology has been used in other urological cancers such as prostate cancer to determine if prostate cancer has spread beyond the gland at the time of prostate removal in real-time. However, it has never been used in this form of bladder cancer operation. If this study proves possible, a larger practice-changing study will be planned to compare this technology against traditional reporting.
Who can participate?
Adult patients undergoing initial or first TURBT for suspected bladder cancer
What does the study involve?
Bladder cancer specimens from subjects undergoing TURBT operation will be stained with a fluorescent dye (Histolog Dip) and scanned on a digital fluorescent confocal microscope (FCM) known as the Histolog Scanner. The specimens will then undergo conventional histopathological analysis. A pathologist will analyse the accuracy of FCM to evaluate detrusor status (presence or absence).
What are the possible benefits and risks of participating?
Patients will derive no direct benefits from taking part. There have been no reported risks from scanning ex vivo tissue using the Histolog scanner.
Where is the study run from?
When is the study starting and how long is it expected to run for?
February 2024 to July 2025
Who is funding the study?
1. The Urology Foundation (TUF) and Chris Howell Urological Research Award from the Penguins Against Cancer Charity (Dr M Connor) are providing funding to Imperial College Healthcare NHS Trust to cover the delivery of the trial excluding the cost of the Histolog scanner and Histolog related consumables.
2. SamanTree Medical SA is providing the Histolog scanner and Histolog-related consumables without any charge.
Who is the main contact?
Dr Martin Connor, m.connor@imperial.ac.uk
Principal Investigator, IB1-LASERComplete
Contact information
Public, Scientific, Principal investigator
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London
W6 8RF
United Kingdom
 ORCID ID |
0000-0003-4033-7508 |
|---|---|
| Phone | +44 (0)20 3313 1000 |
| m.connor@imperial.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective, feasibility design (ex vivo) study |
| Secondary study design | Cohort study |
| Scientific title | 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 |
| Study acronym | IB1-LaserCOMPLETE |
| Study objectives | This study aims to determine the feasibility of using fluorescence confocal microscopy to identify the presence of detrusor muscle in primary transurethral resection of bladder tumour (TURBT) specimens. |
| Ethics approval(s) |
Approved 05/04/2024, Health Research Authority (HRA) - Wales Research Ethics Committee (REC) 3 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)29 2078 5741; Wales.REC3@wales.nhs.uk), ref: 22/WA/0214 |
| Health condition(s) or problem(s) studied | Bladder cancer |
| Intervention | 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 fluorescent confocal microscope (FCM) known as the Histolog Scanner. The specimens will then undergo conventional histopathological analysis. A pathologist will undertake an analysis to evaluate the accuracy of FCM for the evaluation of detrusor status (presence or absence). |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Histolog® Scanner |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Establish a standard operating procedure for scanning fresh bladder tissue from primary TURBTs using the Histolog FCM machine at one timepoint |
| Completion date | 14/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 35 |
| Total final enrolment | 35 |
| Key inclusion criteria | Patients undergoing initial or first transurethral resection of bladder tumour (TURBT) for suspected bladder cancer |
| Key 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 |
| Date of first enrolment | 15/07/2024 |
| Date of final enrolment | 15/01/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
W6 8RF
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr M Connor (m.connor@imperial.ac.uk). Information on the type of data that will be shared will be provided later. The timing for availability is 1 year following completion and/or peer-review publication of the study, whichever is earlier. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | version 1.0 | 11/08/2025 | 27/08/2025 | No | No |
| Statistical Analysis Plan | version 2 | 03/11/2025 | 26/11/2025 | No | No |
Additional files
- ISRCTN16114765_SAP.pdf
- Statistical Analysis Plan
- ISRCTN16114765 IB1-LaserCOMPLETE ISRCTN16114765_SAP_v2 03.11.2025.pdf
- Statistical Analysis Plan
Editorial Notes
26/11/2025: The statistical analysis plan v2 was uploaded as an additional file.
27/08/2025: Statistical analysis plan uploaded.
22/10/2024: Details of funding added to plain English summary.
05/07/2024: Study's existence confirmed by the Imperial College Healthcare Tissue Bank.
