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Gerandomiseerde vergelijking tussen het gebruik van indocyanine groen, patent blauw en radioactiviteit en het gebruik van indocyanine groen en radioactiviteit bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.


- candidate number8853
- NTR NumberNTR2674
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jan-2011
- Secondary IDsP09.001 METC LUMC
- Public TitleGerandomiseerde vergelijking tussen het gebruik van indocyanine groen, patent blauw en radioactiviteit en het gebruik van indocyanine groen en radioactiviteit bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.
- Scientific TitleRandomized comparison of indocyanine green (ICG) combined with patent blue and radioactive colloid versus ICG combined with radioactive colloid alone for sentinel lymph node mapping in breast cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisICG alone combined with radioactivity will perform better than ICG combined with patent blue and radioactivity.
- 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/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2012
- Target number of participants24
- InterventionsA Randomized Single-Institution Superiority Trial comparing standard of care SLN (radioactive tracer and blue dye) + ICG fluorescence and SLN mapping using only radiocolloid (omitting patent blue) + ICG fluorescence in breast cancer patients undergoing SLN procedure.
- 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)
Leiden University Medical Center (LUMC), KWF Kankerbestrijding
- 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 using patent blue and omitting patent blue. In all patients, ICG and radiocolloid will be used.
- Main changes (audit trail)
- RECORD3-jan-2011 - 28-apr-2011


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