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


- candidate number13713
- NTR NumberNTR3685
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2012
- Secondary IDsP09.001 METC LUMC
- Public TitleNabij-infrarode fluorescente beeldvorming gecombineerd met radioactieve colloiden voor de schildwachtklierprocedure in borstkanker patienten.
- Scientific TitleIndocyanine green combined with radioactive colloid for sentinel lymph node mapping in breast cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisA tracer coctail combining indocyanine green and radioactive colloids will allow enhanced detection of the sentinel lymph node in breast cancer patients.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaBreast 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
- Studytypeintervention
- planned startdate 30-aug-2011
- planned closingdate1-jun-2013
- Target number of participants32
- InterventionsA feasibility single-institution trial to assess the use of ICG combined with 99mTc-nanocolloid as a cocktail in SLN mapping in breast cancer patients. Standard-of-care SLN mapping will be performed (blue dye staining and radiocolloid).
Two groups will be formed. Both groups will receive different dose of 99mTc-nanocolloid.
- 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. Difference in signal-to-background ratio between patient groups;
2. Difference in radioactive tracer uptake between patient groups;
3. Number of identified SLNs: Fluorescence and non-fluorescence;
4. In vivo and ex vivo fluorescence intensity of SLNs and radioactivity of the SLNs;
5. Percutaneous lymphatic channel identification at multiple time points.
- 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), KWF Kankerbestrijding
- 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 breast cancer patients.
- Main changes (audit trail)
- RECORD5-nov-2012 - 17-nov-2012


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