Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05273593
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2020-03-19
Brief Title:
Confocal Laser Endomicroscopy During TransUrethral Resection for Improving BC Diagnosis and Treatment
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Confocal Laser Endomicroscopy During TransUrethral Resection for Improving Bladder Cancer Diagnosis and Treatment
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLETUR
Brief Summary:
A prospective monocenter diagnostic accuracy study of Confocal Laser Endomicroscopy CLE for Bladder CancerBC to assess two primary objectives
1 The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy CLE compared to histopathology of the resection specimen
2 The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed radical vs irradical in comparison with histopathology of a biopsy of the resection bed
All patients with a papillary bladder tumor on cystoscopy will be included in this trial
1 The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy CLE compared to histopathology of the resection specimen
2 The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed radical vs irradical in comparison with histopathology of a biopsy of the resection bed
All patients with a papillary bladder tumor on cystoscopy will be included in this trial
Detailed Description:
Rationale
Initial evaluation of gross hematuria consists of White Light Cystoscopy WLC Urine cytology combined with contrast imaging of the upper urothelial tract is performed when a bladder tumor is seen Follow up of non-muscle invasive bladder carcinoma NMIBC after initial treatment consists of similar steps When a suspected lesion is visualized a transurethral resection of the bladder tumor TURBT is performed for therapeutic and diagnostic purposes TURBT is considered to be the gold standard for diagnosis of urothelial carcinoma of the bladder UCB High recurrence rates of UCB after TURBT are reported leading to repetitive surgery and high costs In certain cases of high grade UCB a second look TURBT has proven to be beneficial after primary resection to ensure radical resection Furthermore recent research suggests that active surveillance for low-grade bladder tumors is safe Confocal laser endomicroscopy CLE a high resolution optical imaging technique that can be used in combination with endo-urological procedures seems promising to improve diagnosis of urothelial cancer possibly without the need for immediate transurethral resection to obtain histological confirmation CLE characteristics of UCB have been determined and validated using rigid probes which are incompatible with flexible cystoscopes used for outpatient cystoscopies With the present study we aim to assess the diagnostic value of flexible probe based CLE for diagnosis and grading of UCB Furthermore to possibly prevent second look TURBT in the futurean assessment of CLE features of the resection bed using a rigid CLE-probe will be performed
Objective
Primary objectives
This study is two-fold and therefore has two primary objectives
1 Investigating the diagnostic accuracy of CLE CystoflexF probe during flexible cystoscopy for diagnosis and grading of urothelial carcinoma of the bladder
2 To investigate the diagnostic potential of CLE Cystoflex UHD-R probe for the assessment of the surgical radicality after transurethral resection of a bladder tumor after TURBT
Secondary objective
- To construct a convolutional neural network for computer aided assessment of CLE images for diagnosis and grading of UCB
Study design
This is a prospective monocenter observational diagnostic accuracy study Diagnostic accuracy study to compare the CLE-based diagnosis with the histopathologic findings
Study population All patients 18 years old with a papillary bladder tumor who are planned for TURBT are eligible for this study We will include 60 patients in this pilot study
Intervention At the operation theatre before performing a TURBT for the standard clinical care we introduce a flexible cystoscope to map the bladder then we record CLE images of the index lesion using the CystoflexF Subsequently we replace the flexible scope by the rigid resectoscope We acquire additional images with the Cystoflex UHD-R rigid probe We perform the TURBT After completion of the TURBT we introduce the Cystoflex UHD-R probe again for imaging of the resection bed At a later stage correlation with a standard biopsy of the resection bed will be performed
For CLE imaging a fluorescent contrast agent fluorescein will be used intravesically and intravenously respectively to temporarily stain the extracellular matrix of the urothelium We will introduce fluorescein for intravesical use through a bladder catheter and rinse the fluorescein out of the bladder after an indwelling time of 5-10 minutes Before CLE measurement of the resection bed we will administer fluorescein intravenously
Main study parametersendpoints
1 Overall accuracy sensitivity and specificity of flexible probe CLE-based diagnosis benign vs malignant and grading low-grade versus high-grade in comparison with the histopathology of the resection specimen
2 Overall accuracy sensitivity and specificity of CLE-based assessment of the surgical radicality of the resection bed radical versus irradical in comparison with the histopathology of the biopsy of the resection bed
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants will not benefit directly from this study We hypothesize however that the results of this study will contribute to improvements in the diagnostic and surgical procedure for UCB Outpatient-based cystoscopy with the potential diagnostic certainty of CLE-based grade assessment may enable active surveillance in low-risk UCB and thus may even lead to a reduction in surgical procedures We will introduce a CLE probe before TURBT via the working channel of the flexible cystoscope and hold it in direct contact with the bladder tumor to obtain CLE images Before image acquisition of the bladder tumor we administer fluorescein intravesical which is a fluorescent dye used regularly intravenously in ophthalmatology Before image acquisition of the resection bed we administer fluorescein intravenously In patients not known with an allergy to this dye this is a safe procedure Patients with a known allergic reaction to fluorescein cannot participate in this study Patients will be exposed to approximately 20 minutes of extra surgery time and the introduction of a flexible cystoscope compared to regular TURBT As a result there is little burden to study participation for the patients Adverse events are not expected based on previous experiences The hospitals internal protocol for standard clinical care and histopathologic evaluation are not going to be affected by the study protocol
Initial evaluation of gross hematuria consists of White Light Cystoscopy WLC Urine cytology combined with contrast imaging of the upper urothelial tract is performed when a bladder tumor is seen Follow up of non-muscle invasive bladder carcinoma NMIBC after initial treatment consists of similar steps When a suspected lesion is visualized a transurethral resection of the bladder tumor TURBT is performed for therapeutic and diagnostic purposes TURBT is considered to be the gold standard for diagnosis of urothelial carcinoma of the bladder UCB High recurrence rates of UCB after TURBT are reported leading to repetitive surgery and high costs In certain cases of high grade UCB a second look TURBT has proven to be beneficial after primary resection to ensure radical resection Furthermore recent research suggests that active surveillance for low-grade bladder tumors is safe Confocal laser endomicroscopy CLE a high resolution optical imaging technique that can be used in combination with endo-urological procedures seems promising to improve diagnosis of urothelial cancer possibly without the need for immediate transurethral resection to obtain histological confirmation CLE characteristics of UCB have been determined and validated using rigid probes which are incompatible with flexible cystoscopes used for outpatient cystoscopies With the present study we aim to assess the diagnostic value of flexible probe based CLE for diagnosis and grading of UCB Furthermore to possibly prevent second look TURBT in the futurean assessment of CLE features of the resection bed using a rigid CLE-probe will be performed
Objective
Primary objectives
This study is two-fold and therefore has two primary objectives
1 Investigating the diagnostic accuracy of CLE CystoflexF probe during flexible cystoscopy for diagnosis and grading of urothelial carcinoma of the bladder
2 To investigate the diagnostic potential of CLE Cystoflex UHD-R probe for the assessment of the surgical radicality after transurethral resection of a bladder tumor after TURBT
Secondary objective
- To construct a convolutional neural network for computer aided assessment of CLE images for diagnosis and grading of UCB
Study design
This is a prospective monocenter observational diagnostic accuracy study Diagnostic accuracy study to compare the CLE-based diagnosis with the histopathologic findings
Study population All patients 18 years old with a papillary bladder tumor who are planned for TURBT are eligible for this study We will include 60 patients in this pilot study
Intervention At the operation theatre before performing a TURBT for the standard clinical care we introduce a flexible cystoscope to map the bladder then we record CLE images of the index lesion using the CystoflexF Subsequently we replace the flexible scope by the rigid resectoscope We acquire additional images with the Cystoflex UHD-R rigid probe We perform the TURBT After completion of the TURBT we introduce the Cystoflex UHD-R probe again for imaging of the resection bed At a later stage correlation with a standard biopsy of the resection bed will be performed
For CLE imaging a fluorescent contrast agent fluorescein will be used intravesically and intravenously respectively to temporarily stain the extracellular matrix of the urothelium We will introduce fluorescein for intravesical use through a bladder catheter and rinse the fluorescein out of the bladder after an indwelling time of 5-10 minutes Before CLE measurement of the resection bed we will administer fluorescein intravenously
Main study parametersendpoints
1 Overall accuracy sensitivity and specificity of flexible probe CLE-based diagnosis benign vs malignant and grading low-grade versus high-grade in comparison with the histopathology of the resection specimen
2 Overall accuracy sensitivity and specificity of CLE-based assessment of the surgical radicality of the resection bed radical versus irradical in comparison with the histopathology of the biopsy of the resection bed
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants will not benefit directly from this study We hypothesize however that the results of this study will contribute to improvements in the diagnostic and surgical procedure for UCB Outpatient-based cystoscopy with the potential diagnostic certainty of CLE-based grade assessment may enable active surveillance in low-risk UCB and thus may even lead to a reduction in surgical procedures We will introduce a CLE probe before TURBT via the working channel of the flexible cystoscope and hold it in direct contact with the bladder tumor to obtain CLE images Before image acquisition of the bladder tumor we administer fluorescein intravesical which is a fluorescent dye used regularly intravenously in ophthalmatology Before image acquisition of the resection bed we administer fluorescein intravenously In patients not known with an allergy to this dye this is a safe procedure Patients with a known allergic reaction to fluorescein cannot participate in this study Patients will be exposed to approximately 20 minutes of extra surgery time and the introduction of a flexible cystoscope compared to regular TURBT As a result there is little burden to study participation for the patients Adverse events are not expected based on previous experiences The hospitals internal protocol for standard clinical care and histopathologic evaluation are not going to be affected by the study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None