Bladder CancerNCT02841904
The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
A study testing Confocal LASER Endomicroscopy in people with Bladder Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Confocal LASER Endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2018to Dec 2019
- 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
- First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
- Suspicious mucosa / Carcinoma in situ
- Recurrent pTa
- Positive cytology with normal flexible cystoscopy
- Control after Bacille Calmette Guérin (BCG) treatment
Who cannot join
- Allergy to fluorescein
- Pregnant and lactating women.
- Renal failure (eGFR <20 ml / min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.
Read the detailed description
Confocal Laser Endomicroscopy (CLE) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. CLE aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia.
This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).
Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.
- Conditions
- Bladder Cancer
- Being tested
- Confocal LASER Endomicroscopy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal LASER EndomicroscopyDevice
Also called Cellvisio
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
| Study group | Role | What they receive |
|---|---|---|
| CLE | Other | CLE assessed by the pathologist Receives: Device: Confocal LASER Endomicroscopy |
| Biopsy | Active comparator | Histology assessed by the pathologist Receives: Device: Confocal LASER Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
accordance between CLE and histology in flat bladder tumors
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia
Measured: An average of 18 months
Accordance between CLE and histology in exophytic bladder tumors
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia
Measured: An average of 18 months
Secondary outcomes (2)
Accordance between CLE assessed by the surgeon and histology.
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the surgeon in both flat and exophytic bladder neoplasia
Measured: An average of 18 months
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
Measured: An average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJun 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Beji, MD, Herlev Hospital
- Investigators
- Sami Beji, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841904
- Sponsor's protocol ID
- H-15020548
- Status last verified
- Mar 2018
- First submitted
- 7 Jul 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
- ClinicalTrials.gov ID
- NCT02841904
- Acronym / sponsor ID
- H-15020548
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Jul 2016 (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.
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.
Detailed description
Confocal Laser Endomicroscopy (CLE) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. CLE aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia.
This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).
Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE | Other | Device: Confocal LASER EndomicroscopyCLE assessed by the pathologist |
| Biopsy | Active comparator | Device: Confocal LASER EndomicroscopyHistology assessed by the pathologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
- Suspicious mucosa / Carcinoma in situ
- Recurrent pTa
- Positive cytology with normal flexible cystoscopy
- Control after Bacille Calmette Guérin (BCG) treatment
Key exclusion criteria (3 listed)
- Allergy to fluorescein
- Pregnant and lactating women.
- Renal failure (eGFR <20 ml / min)
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 |
|---|---|---|
| Confocal LASER EndomicroscopyAlso: CellvisioPatients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study. | Device | Biopsy, CLE |
Primary outcome
accordance between CLE and histology in flat bladder tumors
Time frame: An average of 18 months
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia
Accordance between CLE and histology in exophytic bladder tumors
Time frame: An average of 18 months
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia
2 secondary outcomes
Accordance between CLE assessed by the surgeon and histology.
Time frame: An average of 18 months
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
Time frame: An average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- 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.
Sami Beji, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal LASER Endomicroscopy in people with Bladder Cancer, run by Herlev Hospital at 1 site in Denmark.
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 5 inclusion and 3 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 6 Mar 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 Denmark. 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?
Contact Sami Beji, MD (53720546 ext. +45, sami.beji.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accordance between CLE and histology in flat bladder tumors (time frame: An average of 18 months). The study lists 2 primary outcomes in all. 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 6 Mar 2018.