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Nabij-infrarode fluorescente beeldvorming gecombineerd met radioactieve colloiden voor de schildwachtklierprocedure in patienten met huidkanker.


- candidate number14361
- NTR NumberNTR3850
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2013
- Secondary IDsP09.001 METC LUMC
- Public TitleNabij-infrarode fluorescente beeldvorming gecombineerd met radioactieve colloiden voor de schildwachtklierprocedure in patienten met huidkanker.
- Scientific TitleIndocyanine green (ICG) combined with radioactive colloid for sentinel lymph node mapping in melanoma patients.
- ACRONYMGREEN LIGHT
- hypothesisA tracer coctail combining indocyanine green and radioactive colloids will allow enhanced detection of the sentinel lymph node in melonoma patients.
- Healt Condition(s) or Problem(s) studiedMelanoma
- Inclusion criteriaMelanoma 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
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-jul-2013
- Target number of participants20
- InterventionsA feasibility single-institution trial to assess the use of ICG combined with 99mTc-nanocolloid as a cocktail in SLN mapping in melanoma patients. Standard-of-care SLN mapping will be performed (blue dye staining and radiocolloid).
- Primary outcomeNIR fluorescence identification ratio of the SLN, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes were identified using NIR fluorescence.
- Secondary outcome1. Signal to background ratio of the SLNs;
2. Number of identified SLNs: fluorescence a nd non-fluorescence;
3. In vivo and ex vivo fluorescence intensity of SLNs and radioactivity of the SLNs;
4. Percutaneous lymphatic channel identification at multiple time points;
5. Time to identification of SLN.
- TimepointsThe primary and secondary outcomes will be assessed during lymphoscintigraphy, 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 summaryCombining radioactive colloids and a near-infrared fluorophore permits both preoperative planning and intraoperative localization of deeply located sentinel lymph nodes (SLNs) with direct optical guidance using a single lymphatic tracer. This study aims to evaluate and optimize a hybrid NIR fluorescence and radioactive tracer for SLN detection in melanoma patients.
- Main changes (audit trail)
- RECORD11-feb-2013 - 19-feb-2013


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