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Gerandomiseerde vergelijking tussen indocyanine groen en indocyanine groen gekoppeld aan humaan serum albumine bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.


- candidate number8375
- NTR NumberNTR2482
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2010
- Secondary IDsP09.001 METC LUMC
- Public TitleGerandomiseerde vergelijking tussen indocyanine groen en indocyanine groen gekoppeld aan humaan serum albumine bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.
- Scientific TitleRandomized comparison of indocyanine green (ICG) adsorbed to albumin (ICG:HSA) versus ICG alone for sentinel lymph node mapping in breast cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisICG alone without being absorbed to albumin can be used for near-infrared fluorescence SLNB 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
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate1-jan-2011
- Target number of participants18
- InterventionsStandard SLNP will be performed. Before axillary incision, the near-infrared dye ICG:HSA or ICG alone will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively and percutaneously using our experimental camerasystem.
- Primary outcomeSignal-to-background ratio of identified SLNs, defined as the fluorescence intensity of SLN divided by the fluorescence intensity of the surrounding background.
- Secondary outcome1. Number of identified SLNs: fluorescence and non-fluorescence;
2. In vivo and ex vivo fluorescence intensity of SLNs;
3. Identification ratio;
4. Percutaneous lymphatic channel identification;
5. Time to identification of SLN.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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)
ZON-MW, The Netherlands Organization for Health Research and Development, Leiden University Medical Center (LUMC), KWF Kankerbestrijding, Center for Translational Molecular Medicine (CTMM), American Women's Club, Maurits en Anne de Kock Stichting
- 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. Our experimental camera system has been validated in large animal models.
In this study, randomisation will be performed between ICG:HSA and ICG alone.
- Main changes (audit trail)
- RECORD25-aug-2010 - 3-jan-2011


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