Urinary Tract CancerNCT03013920
CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma
An observational study of Urinary Tract Cancer and Urothelial Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Cancer, Urothelial Carcinoma, Ureter Cancer
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Apr 2018
- 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: Adult patients with a suspect tumour in the upper urinary tract, who are planned for a diagnostic URS, are eligible for this study.
Who may be able to join
- Patients >18 years
- Suspect upper urinary tract urothelial carcinoma
- Scheduled for diagnostic URS
- Signed informed consent
Who cannot join
- Patients <18 years
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- Patients not eligible for radical treatment of UTUC
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective In-Vivo Human Pilot Study to Assess Confocal Laser Endomicroscopy Characteristics of Upper Tract Urothelial Carcinoma
Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer. CLE image characteristics for UTUC still have to be defined.
Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively comparing CLE images with both histopathology from diagnostic biopsies and pathology from the therapeutic radical nephroureterectomy. Secondary objectives are the development of an imaging atlas and to assess the technical feasibility and procedure related adverse events of CLE.
Read the detailed description
This study is a prospective, mono-center observational human, in vivo pilot study to assess in-vivo CLE characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract. Eligible patients have a suspect tumour in the upper urinary tract and are scheduled for a diagnostic URS. Eligible patients will be informed about this study by their urologist. Information about the study will be provided both verbally and in written form.
CLE images are recorded using a probe-based system (Cellvizio 100 series, Mauna Kea Technologies, Paris, France). The probe has a diameter of 0,85 mm, hereby enabling passage through the working channel of ureterorenoscope. It has a depth of tissue penetration of 50 µm, a field of view of 320 µm and a resolution of 3,5 µm. Images are collected at a scan rate of 12 frames per second. Using the Cellvizio Viewer system, we 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 (fluoresceinedinatrium, Fresenius Kabi, Zeist, Nederland), a non-toxic and commonly used fluorescent dye will be administered through the working channel of the ureterorenoscope into the pyelocaliceal system (3 - 5 mL 0.1% fluorescein diluted in saline) and left indwelling for 5 minutes to stain the extracellular matrix.
In this study patients will undergo one CLE measurement during the planned diagnostic URS. We measure on average 2 regions of interest per patient. If a patient has multiple tumours we will do multiple measurements. The measurement duration per patient adds maximally 10 minutes during the URS. At a later stage two independent non-blinded observers will review the CLE images. The CLE images of the diagnostic URS are qualitatively compared with histopathology from diagnostic biopsies, and if performed also with pathology from the therapeutic nephroureterectomy.
Based on the UTUC diagnosis from the diagnostic URS, in general about one third of the patients are indicated for a therapeutic radical nephroureterectomy. The other two thirds of the UTUC patients are treated with endoscopic treatment. If patients undergo several ureterorenoscopies, they may be approached for CLE measurements at consecutive ureterorenoscopies.
- Conditions
- Urinary Tract Cancer, Urothelial Carcinoma, Ureter Cancer
- Keywords
- upper urinary tract cancer, confocal laser endomicroscopy, urothelial carcinoma
- Medical subject headings
- Urologic Neoplasms, Carcinoma, Transitional Cell, Ureteral Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
In-vivo CLE measurements of normal urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract
The CLE measurements are qualitatively correlated to the corresponding histopathology
Measured: 3 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 startAug 2016
- Primary completionApr 2018
- Study completionApr 2018
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 Urinary Tract CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- 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
- NCT03013920
- Sponsor's protocol ID
- 2016_088
- 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
- A Prospective In-Vivo Human Pilot Study to Assess Confocal Laser Endomicroscopy Characteristics of Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03013920
- Acronym / sponsor ID
- 2016_088
- Conditions
- Urinary Tract Cancer, Urothelial Carcinoma, Ureter Cancer
- Keywords
- upper urinary tract cancer, confocal laser endomicroscopy, urothelial carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Aug 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (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: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer. CLE image characteristics for UTUC still have to be defined.
Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively comparing CLE images with both histopathology from diagnostic biopsies and pathology from the therapeutic radical nephroureterectomy. Secondary objectives are the development of an imaging atlas and to assess the technical feasibility and procedure related adverse events of CLE.
Detailed description
This study is a prospective, mono-center observational human, in vivo pilot study to assess in-vivo CLE characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract. Eligible patients have a suspect tumour in the upper urinary tract and are scheduled for a diagnostic URS. Eligible patients will be informed about this study by their urologist. Information about the study will be provided both verbally and in written form.
CLE images are recorded using a probe-based system (Cellvizio 100 series, Mauna Kea Technologies, Paris, France). The probe has a diameter of 0,85 mm, hereby enabling passage through the working channel of ureterorenoscope. It has a depth of tissue penetration of 50 µm, a field of view of 320 µm and a resolution of 3,5 µm. Images are collected at a scan rate of 12 frames per second. Using the Cellvizio Viewer system, we 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 (fluoresceinedinatrium, Fresenius Kabi, Zeist, Nederland), a non-toxic and commonly used fluorescent dye will be administered through the working channel of the ureterorenoscope into the pyelocaliceal system (3 - 5 mL 0.1% fluorescein diluted in saline) and left indwelling for 5 minutes to stain the extracellular matrix.
In this study patients will undergo one CLE measurement during the planned diagnostic URS. We measure on average 2 regions of interest per patient. If a patient has multiple tumours we will do multiple measurements. The measurement duration per patient adds maximally 10 minutes during the URS. At a later stage two independent non-blinded observers will review the CLE images. The CLE images of the diagnostic URS are qualitatively compared with histopathology from diagnostic biopsies, and if performed also with pathology from the therapeutic nephroureterectomy.
Based on the UTUC diagnosis from the diagnostic URS, in general about one third of the patients are indicated for a therapeutic radical nephroureterectomy. The other two thirds of the UTUC patients are treated with endoscopic treatment. If patients undergo several ureterorenoscopies, they may be approached for CLE measurements at consecutive ureterorenoscopies.
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
- Adult patients with a suspect tumour in the upper urinary tract, who are planned for a diagnostic URS, are eligible for this study.
Key inclusion criteria (4 listed)
- Patients >18 years
- Suspect upper urinary tract urothelial carcinoma
- Scheduled for diagnostic URS
- Signed informed consent
Key exclusion criteria (5 listed)
- Patients <18 years
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- Patients not eligible for radical treatment of UTUC
- 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
In-vivo CLE measurements of normal urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract
Time frame: 3 years
The CLE measurements are qualitatively correlated to the corresponding histopathology
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 Urinary Tract Cancer 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 5 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?
In-vivo CLE measurements of normal urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract (time frame: 3 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 NCT03013920, 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.