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 |
| Secondary identifying numbers | ICHTB HTA licence: 12275 |
- Submission date
- 04/07/2024
- Registration date
- 20/08/2024
- Last edited
- 22/10/2024
- 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
| Study design | Prospective, feasibility design (ex vivo) study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Diagnostic, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Histolog® Scanner |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 28/02/2024 |
| Completion date | 14/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
London
W6 8RF
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
AHSC Directorate Office
1st Floor
North Corridor
Hammersmith Hospital
London
W12 0HS
England
United Kingdom
| Phone | +44 (0)20 3313 1000 |
|---|---|
| donna.copeland@nhs.net | |
| Website | https://www.imperial.nhs.uk/ |
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Imperial College of Science, Technology and Medicine, Imperial College London, UK, Imperial College London, London, England, Imperial College London in United Kingdom, imperialcollege, ICL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer-reviewed journals, national and international conferences |
| 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. |
Editorial Notes
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.
