Imperial Prostate 8 - fluorescence confocal microscopy for rapid evaluation of surgical cancer excision
| ISRCTN | ISRCTN21536411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21536411 |
| Secondary identifying numbers | 12275 |
- Submission date
- 01/08/2023
- Registration date
- 09/10/2023
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
This study aims to evaluate the use of a new imaging technique called fluorescence confocal microscopy (FCM) for real-time identification of positive surgical margins in prostate cancer surgery. Positive surgical margins (PSMs) occur when cancer cells are found at the edge of the removed tissue after surgery. Detecting PSMs accurately is important to ensure complete cancer removal during prostate cancer surgery.
Who can participate?
Patients over the age of 18 years with prostate cancer undergoing radical prostatectomy (surgical removal of the prostate) at Imperial College Healthcare NHS Trust, University College London Hospitals NHS Foundation Trust, or Guy's & St Thomas' NHS Foundation Trust during the study period
What does the study involve?
Participants scheduled for prostate cancer surgery will undergo the standard robotic-assisted surgical procedure. During the surgery, a new imaging technique called FCM will be used to scan the removed prostate tissue. FCM uses fluorescent dyes to enhance cell visibility, providing real-time high-resolution images of the tissue. These images will be compared to traditional histopathology (examination of tissue samples under a microscope) to determine the accuracy of FCM in detecting positive surgical margins.
What are the possible benefits and risks of participating?
The potential benefits of participating in the study include contributing to the evaluation of a new imaging technique that could improve the accuracy of detecting positive surgical margins during prostate cancer surgery, leading to better cancer treatment outcomes.
There are no specific risks associated with participating in the study, as it involves the use of an ex vivo (outside the body) imaging technique. Any risks associated with the surgical procedure itself will be managed according to the standard of care.
Where is the study run from?
Imperial College Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
November 2022 to August 2024
Who is funding the study?
1. The Urology Foundation (TUF) (UK)
2. The John Black Charitable Foundation (UK)
Who is the main contact?
Mr Nikhil Mayor, n.mayor@imperial.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-way-to-assess-tissue-samples-taken-during-prostate-surgery-ip8-fluoresce
Contact information
Principal Investigator
Imperial Prostate
Department of Surgery and Cancer
Imperial College London, Hammersmith Campus
72 Du Cane Road
London
W12 0HS
United Kingdom
 ORCID ID |
0000-0003-2681-2501 |
|---|---|
| Phone | +44 (0)20 3313 1000 |
| n.mayor@imperial.ac.uk |
Public
Imperial Prostate
Department of Surgery and Cancer
Imperial College London, Hammersmith Campus
72 Du Cane Rd
London
W12 0HS
United Kingdom
| Phone | +44 (0)20 3313 1000 |
|---|---|
| n.mayor@imperial.ac.uk |
Study information
| Study design | Multicentre ex-vivo single-centre blinded prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Laboratory |
| 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 multicentre blinded prospective cohort study to assess the accuracy of digital fluorescence confocal microscopy for assessment of surgical margins in radical prostatectomy specimens |
| Study acronym | IP8-FLUORESCE |
| Study hypothesis | This study aims to evaluate whether digital fluorescence confocal microscopy can accurately detect positive surgical margins in patients undergoing radical prostatectomy for localised prostate cancer. |
| Ethics approval(s) |
Approved 10/05/2023, Wales REC3 (Health and Care Research Wales Support Centre, 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 |
| Condition | Prostate cancer |
| Intervention | Prostate specimens from subjects undergoing radical prostatectomy (RP) 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 a blinded analysis to evaluate the accuracy of FCM for evaluation of surgical margins in prostate cancer. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Histolog® Scanner |
| Primary outcome measure | Accuracy of digital FCM measured using the Histolog Scanner in detecting clinically significant prostate cancer at surgical margins at radical prostatectomy compared to traditional H&E histopathology (reference standard). Measures used to assess accuracy will be sensitivity, specificity, positive and negative predictive value. Clinically significant cancer is defines as Gleason score >/= 7 (ISUP Grade Group >/=2). |
| Secondary outcome measures | 1. Sensitivity, specificity, positive and negative predictive value of digital FCM for detection of cancer at surgical margins, with traditional H&E histopathology as the reference standard, on a per-image/margin level 2. Area under the receiver operating characteristic curve (AUC) for cancer detection of digital FCM with traditional H&E histopathology as the reference standard 3. Agreement of digital FCM with the pathology report for cancer length at margin (mm) on a margin and patient level 4. Agreement of digital FCM with the pathology report for cancer grade at margin (mm) on a margin and patient level 5. Cohen’s kappa coefficient for agreement between readers (two individual histopathologists, histopathologist vs trainee histopathologist, histopathologist vs urologist) |
| Overall study start date | 30/11/2022 |
| Overall study end date | 01/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 155 |
| Participant inclusion criteria | 1. Men aged >/=18 years 2. Men undergoing radical prostatectomy at Imperial College Healthcare NHS Trust during the study period 3. Nerve sparing and non-nerve sparing radical prostatectomy cases |
| Participant exclusion criteria | Current exclusion criteria as of 09/05/2024: 1. Men who do not consent for ex vivo tissue research 2. Men who are listed for salvage prostatectomy and had a previous prostate cancer treatment (radiotherapy, brachytherapy, focal therapy) _____ Previous exclusion criteria: 1. Men who do not consent for ex vivo tissue research through Imperial College Healthcare Tissue Bank (ICHTB) 2. Men who are listed for salvage prostatectomy and had a previous prostate cancer treatment (radiotherapy, brachytherapy, focal therapy) 3. Men enrolled in concurrent clinical trials requiring ex vivo prostatic tissue for research |
| Recruitment start date | 17/08/2023 |
| Recruitment end date | 30/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W6 8RF
United Kingdom
London
NW1 2PG
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
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 | http://www.imperial.nhs.uk/ |
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- TUF
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The John Black Charitable Foundation, JBCF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be presented at national and international urological meetings in the UK and abroad. Planned publication in a peer-reviewed urological journal. |
| IPD sharing plan | The datasets generated during the study will be available upon request from Nikhil Mayor (n.mayor@imperial.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 02/04/2024 | 09/05/2024 | No | No |
Additional files
Editorial Notes
04/06/2024: Cancer Research UK link added to plain English summary field.
09/05/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The scientific title was changed from "A prospective paired-cohort confirmatory study to assess the accuracy of digital fluorescence confocal microscopy for assessment of surgical margins in radical prostatectomy specimens" to "A multicentre blinded prospective cohort study to assess the accuracy of digital fluorescence confocal microscopy for assessment of surgical margins in radical prostatectomy specimens".
3. The study design was changed from "Ex vivo single-centre blinded prospective paired-cohort confirmatory study" to "Multicentre ex-vivo single-centre blinded prospective cohort study".
4. The target number of participants was changed from 100 to 155.
5. The exclusion criteria were changed.
6. The recruitment end date was changed from 31/01/2024 to 30/06/2024.
7. The study participating centres University College London Hospitals NHS Foundation Trust and Guy's and St Thomas' Hospitals were added.
8. The plain English summary was updated to reflect these changes.
15/08/2023: Trial's existence confirmed by The Urology Foundation (UK).
