Bladder NeoplasmNCT03013894
Confocal Laser Endomicroscopy in the Lower Urinary Tract
An observational study of Bladder Neoplasm and Urothelial Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasm, Urothelial Carcinoma
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Oct 2017
- Phase
- Observational
- 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
Study population: Patients >18 years old with primary or recurrent bladder tumor(s), who are scheduled for TURB are eligible for this study.
Who may be able to join
- Patients >18 years old
- Bladder tumor(s)
- Candidate for TURB
- Signed informed consent
Who cannot join
- Patients <18 years old
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis
Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined.
Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.
Read more
Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology.
Secondary objectives:
- Assessing procedure related adverse events of CLE
- Assessing technical feasibility of CLE
- To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)
Read the detailed description
This is a prospective, multicenter, observational study; the investigators will establish sensitivity and specificity of CLE ex vivo and in vivo, in the diagnosis of bladder carcinoma.
Eligible patients are diagnosed with a bladder tumor at the outpatient clinic and scheduled for transurethral resection of bladder tumor (TURB). In total the investigators want to include 60 patients. Yearly approximately 70 patients are diagnosed with primary and recurrent bladder carcinoma in the Academic Medical Center (AMC) and will undergo TURB.
Their Urologist will inform patients diagnosed with a bladder tumor who will be scheduled for treatment by means of TURB about the study. Information about the study will be provided both orally and in written form.
CLE images are recorded using a probe-based system (Cellvizio 100 series, Mauna Kea Technologies, Paris, France). The probe (Cystoflex UHD-R, Mauna Kea Technologies, Paris, France) has an outer diameter of 2.8 mm, a field of view of 240 µm and has a resolution of 1 µm. Images are collected at a scan rate of 12 frames per second. Using the Cellvizio Viewer system, the investigators can observe mucosal microarchitecture with an increased field of view through mosaic post processing. This system also enables virtual staining of mucosal structures to further enhance tissue contrast.
A fluorescent contrast agent is needed to obtain CLE images. Fluorescein (fluoresceinedisodium, Fresenius Kabi, Zeist, Netherlands), a non-toxic and commonly used fluorescent dye will be administered intravesical (300-400 mL 0.1% fluorescein diluted in saline) and left indwelling for 5 minutes to stain the extracellular matrix.
The study consists of three CLE measurements, one in vivo prior to tumor resection, the second ex vivo of the resected specimen, and the last measurement is ex vivo after fixating the tumor on formaldehyde. In the case of multiple tumors, multiple CLE measurements will be done. The measurement per-operatively will add approximately 15 minutes to operating time. In the ex vivo set up, additional images will be acquired using Optical Coherence Tomography (OCT). During tumor resection, a small chip of normal urothelium will be resected additionally to act as control. Resected bladder tissue will be fixed and laminated by the pathology department, to correlate to CLE images.
- Conditions
- Bladder Neoplasm, Urothelial Carcinoma
- Keywords
- bladder neoplasm, urothelium carcinoma, confocal laser endomicroscopy
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract
Qualitatively correlating CLE images to histopathology to define CLE characteristics
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder NeoplasmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. J.J.M.C.H. de la Rosette, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jean J de la Rosette, prof. dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013894
- Sponsor's protocol ID
- 2015_300
- Status last verified
- Jun 2018
- First submitted
- 28 Dec 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liem EI, Freund JE, Baard J, de Bruin DM, Laguna Pes MP, Savci-Heijink CD, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Confocal Laser Endomicroscopy for the Diagnosis of Urothelial Carcinoma in the Bladder and the Upper Urinary Tract: Protocols for Two Prospective Explorative Studies. JMIR Res Protoc. 2018 Feb 7;7(2):e34. doi: 10.2196/resprot.8862.
PubMed 29415874
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT03013894
- Acronym / sponsor ID
- 2015_300
- Conditions
- Bladder Neoplasm, Urothelial Carcinoma
- Keywords
- bladder neoplasm, urothelium carcinoma, confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- 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.
Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined.
Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.
Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology.
Secondary objectives:
- Assessing procedure related adverse events of CLE
- Assessing technical feasibility of CLE
- To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)
Detailed description
This is a prospective, multicenter, observational study; the investigators will establish sensitivity and specificity of CLE ex vivo and in vivo, in the diagnosis of bladder carcinoma.
Eligible patients are diagnosed with a bladder tumor at the outpatient clinic and scheduled for transurethral resection of bladder tumor (TURB). In total the investigators want to include 60 patients. Yearly approximately 70 patients are diagnosed with primary and recurrent bladder carcinoma in the Academic Medical Center (AMC) and will undergo TURB.
Their Urologist will inform patients diagnosed with a bladder tumor who will be scheduled for treatment by means of TURB about the study. Information about the study will be provided both orally and in written form.
CLE images are recorded using a probe-based system (Cellvizio 100 series, Mauna Kea Technologies, Paris, France). The probe (Cystoflex UHD-R, Mauna Kea Technologies, Paris, France) has an outer diameter of 2.8 mm, a field of view of 240 µm and has a resolution of 1 µm. Images are collected at a scan rate of 12 frames per second. Using the Cellvizio Viewer system, the investigators can observe mucosal microarchitecture with an increased field of view through mosaic post processing. This system also enables virtual staining of mucosal structures to further enhance tissue contrast.
A fluorescent contrast agent is needed to obtain CLE images. Fluorescein (fluoresceinedisodium, Fresenius Kabi, Zeist, Netherlands), a non-toxic and commonly used fluorescent dye will be administered intravesical (300-400 mL 0.1% fluorescein diluted in saline) and left indwelling for 5 minutes to stain the extracellular matrix.
The study consists of three CLE measurements, one in vivo prior to tumor resection, the second ex vivo of the resected specimen, and the last measurement is ex vivo after fixating the tumor on formaldehyde. In the case of multiple tumors, multiple CLE measurements will be done. The measurement per-operatively will add approximately 15 minutes to operating time. In the ex vivo set up, additional images will be acquired using Optical Coherence Tomography (OCT). During tumor resection, a small chip of normal urothelium will be resected additionally to act as control. Resected bladder tissue will be fixed and laminated by the pathology department, to correlate to CLE images.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years old with primary or recurrent bladder tumor(s), who are scheduled for TURB are eligible for this study.
Key inclusion criteria (4 listed)
- Patients >18 years old
- Bladder tumor(s)
- Candidate for TURB
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients <18 years old
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- No signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract
Time frame: 1.5 years
Qualitatively correlating CLE images to histopathology to define CLE characteristics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 29415874Liem EI, Freund JE, Baard J, de Bruin DM, Laguna Pes MP, Savci-Heijink CD, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Confocal Laser Endomicroscopy for the Diagnosis of Urothelial Carcinoma in the Bladder and the Upper Urinary Tract: Protocols for Two Prospective Explorative Studies. JMIR Res Protoc. 2018 Feb 7;7(2):e34. doi: 10.2196/resprot.8862.
- Individual participant dataSharing planned: No
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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.
Jean J de la Rosette, prof. dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Neoplasm and Urothelial Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Jun 2018. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013894, which also lists 1 linked publication.
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 6 Jun 2018.