Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT03013894
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Laser Endomicroscopy in the Lower Urinary Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'CLE images (without DNA) and histopathology (with DNA)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract', 'timeFrame': '1.5 years', 'description': 'Qualitatively correlating CLE images to histopathology to define CLE characteristics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bladder neoplasm', 'urothelium carcinoma', 'confocal laser endomicroscopy'], 'conditions': ['Bladder Neoplasm', 'Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29415874', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nObjective: 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.\n\nPrimary 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.\n\nSecondary objectives:\n\n* Assessing procedure related adverse events of CLE\n* Assessing technical feasibility of CLE\n* To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)", 'detailedDescription': '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.\n\nEligible 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.\n\nTheir 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.\n\nCLE 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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\>18 years old with primary or recurrent bladder tumor(s), who are scheduled for TURB are eligible for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years old\n* Bladder tumor(s)\n* Candidate for TURB\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients \\<18 years old\n* Patients with known allergy for fluorescein\n* Possible pregnancy or lactating women\n* No signed informed consent'}, 'identificationModule': {'nctId': 'NCT03013894', 'briefTitle': 'Confocal Laser Endomicroscopy in the Lower Urinary Tract', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis', 'orgStudyIdInfo': {'id': '2015_300'}}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Jean J de la Rosette, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof.dr. J.J.M.C.H. de la Rosette', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}