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Intra-operatieve fluorescente beeldvorming van schildwachtklieren bij blaaskankerpatienten.


- candidate number13426
- NTR NumberNTR3657
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2012
- Secondary IDsP09.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van schildwachtklieren bij blaaskankerpatienten.
- Scientific TitleIntra-operative fluorescent imaging of sentinel lymph nodes in bladder cancer.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can accurately detect lymph nodes non-invasively during SLN mapping in bladder cancer patients.
- Healt Condition(s) or Problem(s) studiedBladder carinoma
- Inclusion criteriaBladder cancer patients planned to undergo a wide local excision and lymphadenectomy.
- Exclusion criteria1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin;
2. Pregnancy;
3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2013
- Target number of participants15
- InterventionsStandard lymphadectomy will be performed. Before surgery, the near-infrared dye ICG:HSA will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively using our experimental camerasystem.
- Primary outcomeIdentification rate, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified percutaneously with the fluorescent signal of ICG:HSA.
- Secondary outcome1. Median number of lymph nodes identified with ICG:HSA;
2. Sensitivity: percentage of patients in whom fluorescent lymph nodes were identified of the total patients with identified sentinel lymph nodes by standard SNB technique;
3. signal-to-background ratio.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryA new and still experimental lymphadenectomy approach in bladder cancer is to identify, remove, and analyze a sentinel lymph node (SLN) or nodes. Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes. We hypothesize that an ICG coupled to human serum albumin would provide a highly sensitive, high-resolution image of SLNs.
- Main changes (audit trail)
- RECORD9-okt-2012 - 22-okt-2012


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