search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number9369
- NTR NumberNTR2871
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2011
- 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 vulva kanker patienten.
- Scientific TitleRandomized comparison of indocyanine green (ICG) adsorbed to albumin (ICG:HSA) versus ICG alone for sentinel lymph node mapping in vulvar cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisICG alone without being absorbed to albumin can be used for near-infrared fluorescence SLNB 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
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-aug-2012
- Target number of participants24
- InterventionsStandard SLNP will be performed. Before incision, the near-infrared dye ICG:HSA of 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
- 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 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)
- RECORD27-apr-2011 - 6-mei-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl