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Intraoperatieve detectie van de schildwachtklier met indocyanine groen gecombineerd met radioactief Nanocoll bij vulva kanker patienten.


- candidate number14360
- NTR NumberNTR3849
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2013
- Secondary IDsP09.001 METC Leiden
- Public TitleIntraoperatieve detectie van de schildwachtklier met indocyanine groen gecombineerd met radioactief Nanocoll bij vulva kanker patienten.
- Scientific TitleIndocyanine green combined with radioactive colloid for sentinel lymph node mapping in vulvar cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisICG combined with 99Tc-Nanocoll can be used as fluorescent tracer in sentinel lymph node mapping in vulvar cancer patients.
- Healt Condition(s) or Problem(s) studiedVulvar cancer
- Inclusion criteriaVulvar cancer patients planned to undergo a sentinel lymph node procedure.
- 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
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2013
- planned closingdate1-jun-2014
- Target number of participants20
- InterventionsStandard SLNP will be performed. One day before surgery or the day of surgery. 99TC-Nanocoll-ICG will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively and percutaneously using our experimental camerasystem during surgery.
- Primary outcome1. The proportion of patients in whon sentinel and non-sentinel lymph nodes can be identified;
2. Difference in signal-to-background ratio between different injection groups.
- Secondary outcome1. Carrelation between fluorescent and radioactove nodes;
2. The correlation between the quantitative fluorescence signal and quantitative radioactive signal.
- 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 summaryAlthough sentinel lymph node procedure (SLNP) is regarded standard of care, the technique is not optimal and it requires involvement of ionizing radiation. Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes. In previous experiment we succesfully identifies SLNs with fluorescent imaging. In this study, a combined fluorescent and radioactive probe is used for SLN identification.
- Main changes (audit trail)
- RECORD11-feb-2013 - 19-feb-2013


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