Bladder Urothelial CarcinomaNCT03138824
Storz Professional Image Enhancement System Versus White Light Imaging Assisted TURBT for Treatment of NMIBC
A study testing SPIES assisted TURBT and WLI assisted TURBT in people with Bladder Urothelial Carcinoma and TURBT, run by Mansoura University at 1 site in Egypt.
Trial summary
Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients with non-muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma, TURBT, Bladder Neoplasm
- What is being tested?
- SPIES assisted TURBT and WLI assisted TURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed at the out-patient cystoscopy with papillary bladder or small resectable lesion that can be resected tumour
Who cannot join
- Tumor criteria
- Beyond scope of resection
- Patients criteria
- Poor performance status
- History of bladder irradiation
- Contracted bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Storz Professional Image Enhancement System (SPIES) Versus Conventional White Light Imaging (WLI) Assisted Transurethral Resection of Bladder Tumour (TURBT) for Treatment of Non-muscle Invasive Bladder Cancer (NMIBC)
Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients with non-muscle invasive bladder cancer.
Read the detailed description
Urothelial carcinoma of the bladder is the 2nd most common urological malignancy. The vast majority of newly diagnosed cases are non-muscle invasive bladder cancers (NMIBC), which represent about 75%, and it can be treated with transurethral resection (TURBT). The goal of TURBT in Ta and T1 NMIBC is to make the correct diagnosis and completely remove all visible lesions. The quality of TURBT strongly determines patient prognosis and overall treatment.
White light cystoscopy (WLC) remains despite of its limitations the cornerstone of the diagnosis and subsequent treatment of NMIBC. The sensitivity and specificity of WLC range from 62% to 84% and 43% to 98%, respectively. Its sensitivity is lower for small papillary bladder tumors and carcinoma in situ (CIS). Moreover, the accuracy of WLC has been shown to be operator dependent.
Smaller or satellite tumors can be missed, which contributes to almost 40% rate of residual bladder cancer found at the time of 'second-look' TUR. Indistinct borders and difficult visualization of submucosal tumor margins during TUR can lead to incomplete tumor resection and understaging of bladder cancer and leads to tumor recurrence which range from 15% to 61% at one year after surgery based on combined analysis of seven EORTC studies. 3 Non-papillary and flat malignant lesions such as carcinoma in situ (CIS) can be difficult to differentiate from inflammation, with detection rates of CIS only 58% to 68% by WLC.
Fluorescence cystoscopy also known as blue light cystoscopy or photodynamic diagnosis (PDD) requires preoperative intravesical administration of protoporphyrin IX precursor as the contrast agent, a blue light source that illuminates at 375 to 440 nm. Protoporphyrin accumulates preferentially in neoplastic cells and emits fluorescence in the red part of the spectrum under blue light excitation. Though PDD also does not distinguish high-grade from low-grade bladder cancer, PDD has an increased rate of detection of flat appearing CIS vs WLC (87% vs 75% pooled sensitivity; P= .006).
The recurrence rate of PDD-guided TUR of bladder tumor is a matter of controversy. In a meta-analysis of prospective studies on 1345 patients with overall 12 months recurrence rate was significantly lower with PDD compared with WLC (34.5% vs 45.4% pooled sensitivity; P=0.006). However, a prospective randomized multi-institutional trial found no difference in tumor recurrence and progression between PDD and WLC.
Narrow band maging (NBI) devices filter out the red spectrum from white light, with the resultant blue (415 nm) and green (540 nm) spectra absorbed by hemoglobin, thus highlighting the contrast between capillaries and mucosa with no significant difference in detection rate of bladder tumor between new and experienced users. Under NBI, the more vascularized CIS or tumor areas are accentuated in appearance as green or brown. However visibility of NBI cystoscopy is reduced with bleeding or inflammation, due to the strong absorption of light by hemoglobin. In contrast to PDD, systems integrating WLC and NBI are already available. In a recent meta-analysis of 8 studies including 1022 patients, the detection of bladder cancer was higher by NBI compared with WLC on a per-person basis (94% vs 85% pooled sensitivity) and a per-lesion basis (95% vs 75% pooled sensitivity); however, the pooled specificity on a per-lesion basis was lower by NBI compared with WLC (55% vs 72%).
Similar to PDD, NBI does not distinguish bladder cancer grade. The detection of CIS was significantly improved by NBI over WLC (100% vs 83% sensitivity) in a study of 427 patients. Another multicenter, prospective study reported a significantly increased sensitivity for the detection of CIS from 50% for WLC to 90% for NBI in 104 patients. In a recent, single-center, randomized, controlled trial to assess whether NBI improved TUR of bladder tumors in 254 patients with 2-year follow-up, a reduced recurrence rate (22% vs 33%; P=.05) and improved recurrence-free survival (22 vs 19 months; P =.02) were reported by NBI compared with WLC.
Storz Professional Image Enhancement System (SPIES) offers several image enhancement modalities: Spectra A mode is based mainly on the green (~500-570 nm) and blue (~400-480 nm) light spectral signals that are separated in the (Red-Green-Blue) of the camera system within these bands the hemoglobin absorption is significantly higher compared to the red spectral band above 570 nm. Due to the limited penetration depth in the blue to green spectral part, this mode allows to highlight the contrast of capillaries and vessels in the superficial mucosa and submucosa. The SPIES Spectra B pronounces as well as the Spectra A mode the blue to green spectral part in order to reach a higher contrast in the superficial mucosa and sub mucosa. However SPECTRA B is obtained by adding 15% of red colour to SPECTRA A. The Chroma modality enhance the sharpness of the image. The Clara modality create a clearer image of darker regions within the image. Together they should provide a clearer and sharper image of the original WL image.
SPIES enhances the blue and the green wavelengths of the transmitted image and a three-colour image is built from these components of the spectral input. This effect is achieved by suppression of the red portion of the spectrum. By adding different colours to the blue- and green-coloured image (e.g. orange or violet), three types of SPIES images are produced, giving the surgeon three different options for visualization. SPIES proposes the option to choose the best enhancement method in different clinical situations, e.g. SPIES A or C mode, if high contrast is desired or SPIES B mode in case of visual interferences during cystoscopy as hematuria.
- Conditions
- Bladder Urothelial Carcinoma, TURBT, Bladder Neoplasm, Cystoscopy
- Being tested
- SPIES assisted TURBT, WLI assisted TURBT
- Keywords
- Bladder Urothelial Carcinoma, TURBT, Recurrence, Progression
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIES assisted TURBTProcedure or surgery
Also called Storz Professional Image Enhancement System (SPIES)
SPIES assisted TURBT of NMIBC
WLI assisted TURBTProcedure or surgery
Also called White Light Imaging (WLI)
White Light Imaging (WLI) assisted TURBT for treatment of NMIBC
| Study group | Role | What they receive |
|---|---|---|
| SPIES assisted TURBT | Experimental | Storz Professional Image Enhancement System (SPIES) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer Receives: Procedure: SPIES assisted TURBT |
| WLI assisted TURBT | Experimental | White Light Imaging (WLI) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer Receives: Procedure: WLI assisted TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence after TURBT in patients with NMIBC
inpatient cystoscopy of the tumor site for detection of tumor recurrence disease in each arm
Measured: 3 months after primary procedure
Secondary outcomes (1)
1-year recurrence free survival
Number of patients surviving for one year without tumor recurrence will be counted and compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 May 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Ahmed Mosbah, MD, Phd, Study chair, Urology and Nephrology CenterBedir Ali-Eldeen, MD, Phd, Study director, Urology and Nephrology CenterAhmed Elshal, MD, Study director, Urology and Nephrology CenterAbdelwahab Hashem, Msc, Principal investigator, Urology and Nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138824
- Sponsor's protocol ID
- MS/17.03.57
- Status last verified
- May 2017
- First submitted
- 1 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Ahmed Elshal, MD
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Storz Professional Image Enhancement System (SPIES) Versus Conventional White Light Imaging (WLI) Assisted Transurethral Resection of Bladder Tumour (TURBT) for Treatment of Non-muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT03138824
- Acronym / sponsor ID
- MS/17.03.57
- Conditions
- Bladder Urothelial Carcinoma, TURBT, Bladder Neoplasm, Cystoscopy
- Keywords
- Bladder Urothelial Carcinoma, TURBT, Recurrence, Progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients with non-muscle invasive bladder cancer.
Detailed description
Urothelial carcinoma of the bladder is the 2nd most common urological malignancy. The vast majority of newly diagnosed cases are non-muscle invasive bladder cancers (NMIBC), which represent about 75%, and it can be treated with transurethral resection (TURBT). The goal of TURBT in Ta and T1 NMIBC is to make the correct diagnosis and completely remove all visible lesions. The quality of TURBT strongly determines patient prognosis and overall treatment.
White light cystoscopy (WLC) remains despite of its limitations the cornerstone of the diagnosis and subsequent treatment of NMIBC. The sensitivity and specificity of WLC range from 62% to 84% and 43% to 98%, respectively. Its sensitivity is lower for small papillary bladder tumors and carcinoma in situ (CIS). Moreover, the accuracy of WLC has been shown to be operator dependent.
Smaller or satellite tumors can be missed, which contributes to almost 40% rate of residual bladder cancer found at the time of 'second-look' TUR. Indistinct borders and difficult visualization of submucosal tumor margins during TUR can lead to incomplete tumor resection and understaging of bladder cancer and leads to tumor recurrence which range from 15% to 61% at one year after surgery based on combined analysis of seven EORTC studies. 3 Non-papillary and flat malignant lesions such as carcinoma in situ (CIS) can be difficult to differentiate from inflammation, with detection rates of CIS only 58% to 68% by WLC.
Fluorescence cystoscopy also known as blue light cystoscopy or photodynamic diagnosis (PDD) requires preoperative intravesical administration of protoporphyrin IX precursor as the contrast agent, a blue light source that illuminates at 375 to 440 nm. Protoporphyrin accumulates preferentially in neoplastic cells and emits fluorescence in the red part of the spectrum under blue light excitation. Though PDD also does not distinguish high-grade from low-grade bladder cancer, PDD has an increased rate of detection of flat appearing CIS vs WLC (87% vs 75% pooled sensitivity; P= .006).
The recurrence rate of PDD-guided TUR of bladder tumor is a matter of controversy. In a meta-analysis of prospective studies on 1345 patients with overall 12 months recurrence rate was significantly lower with PDD compared with WLC (34.5% vs 45.4% pooled sensitivity; P=0.006). However, a prospective randomized multi-institutional trial found no difference in tumor recurrence and progression between PDD and WLC.
Narrow band maging (NBI) devices filter out the red spectrum from white light, with the resultant blue (415 nm) and green (540 nm) spectra absorbed by hemoglobin, thus highlighting the contrast between capillaries and mucosa with no significant difference in detection rate of bladder tumor between new and experienced users. Under NBI, the more vascularized CIS or tumor areas are accentuated in appearance as green or brown. However visibility of NBI cystoscopy is reduced with bleeding or inflammation, due to the strong absorption of light by hemoglobin. In contrast to PDD, systems integrating WLC and NBI are already available. In a recent meta-analysis of 8 studies including 1022 patients, the detection of bladder cancer was higher by NBI compared with WLC on a per-person basis (94% vs 85% pooled sensitivity) and a per-lesion basis (95% vs 75% pooled sensitivity); however, the pooled specificity on a per-lesion basis was lower by NBI compared with WLC (55% vs 72%).
Similar to PDD, NBI does not distinguish bladder cancer grade. The detection of CIS was significantly improved by NBI over WLC (100% vs 83% sensitivity) in a study of 427 patients. Another multicenter, prospective study reported a significantly increased sensitivity for the detection of CIS from 50% for WLC to 90% for NBI in 104 patients. In a recent, single-center, randomized, controlled trial to assess whether NBI improved TUR of bladder tumors in 254 patients with 2-year follow-up, a reduced recurrence rate (22% vs 33%; P=.05) and improved recurrence-free survival (22 vs 19 months; P =.02) were reported by NBI compared with WLC.
Storz Professional Image Enhancement System (SPIES) offers several image enhancement modalities: Spectra A mode is based mainly on the green (~500-570 nm) and blue (~400-480 nm) light spectral signals that are separated in the (Red-Green-Blue) of the camera system within these bands the hemoglobin absorption is significantly higher compared to the red spectral band above 570 nm. Due to the limited penetration depth in the blue to green spectral part, this mode allows to highlight the contrast of capillaries and vessels in the superficial mucosa and submucosa. The SPIES Spectra B pronounces as well as the Spectra A mode the blue to green spectral part in order to reach a higher contrast in the superficial mucosa and sub mucosa. However SPECTRA B is obtained by adding 15% of red colour to SPECTRA A. The Chroma modality enhance the sharpness of the image. The Clara modality create a clearer image of darker regions within the image. Together they should provide a clearer and sharper image of the original WL image.
SPIES enhances the blue and the green wavelengths of the transmitted image and a three-colour image is built from these components of the spectral input. This effect is achieved by suppression of the red portion of the spectrum. By adding different colours to the blue- and green-coloured image (e.g. orange or violet), three types of SPIES images are produced, giving the surgeon three different options for visualization. SPIES proposes the option to choose the best enhancement method in different clinical situations, e.g. SPIES A or C mode, if high contrast is desired or SPIES B mode in case of visual interferences during cystoscopy as hematuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIES assisted TURBT | Experimental | Procedure: SPIES assisted TURBTStorz Professional Image Enhancement System (SPIES) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer |
| WLI assisted TURBT | Experimental | Procedure: WLI assisted TURBTWhite Light Imaging (WLI) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed at the out-patient cystoscopy with papillary bladder or small resectable lesion that can be resected tumour
Key exclusion criteria (6 listed)
- Tumor criteria
- Patients criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIES assisted TURBTAlso: Storz Professional Image Enhancement System (SPIES)SPIES assisted TURBT of NMIBC | Procedure or surgery | SPIES assisted TURBT |
| WLI assisted TURBTAlso: White Light Imaging (WLI)White Light Imaging (WLI) assisted TURBT for treatment of NMIBC | Procedure or surgery | WLI assisted TURBT |
Primary outcome
Tumor recurrence after TURBT in patients with NMIBC
Time frame: 3 months after primary procedure
inpatient cystoscopy of the tumor site for detection of tumor recurrence disease in each arm
1 secondary outcome
1-year recurrence free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Ahmed Elshal, MD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mosbah, MD, Phd study chair
Urology and Nephrology Center
Bedir Ali-Eldeen, MD, Phd study director
Urology and Nephrology Center
Ahmed Elshal, MD study director
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIES assisted TURBT and WLI assisted TURBT in people with Bladder Urothelial Carcinoma and TURBT, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence after TURBT in patients with NMIBC (time frame: 3 months after primary procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.