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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 baarmoederhalskankerpatienten.


- candidate number9368
- NTR NumberNTR2870
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2011
- Secondary IDsP09.001 CME LUMC
- Public TitleGerandomiseerde vergelijking tussen indocyanine groen en indocyanine groen gekoppeld aan humaan serum albumine bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij baarmoederhalskankerpatienten.
- Scientific TitleRandomized comparison of indocyanine green (ICG) adsorbed to albumin (ICG:HSA) versus ICG alone for sentinel lymph node mapping in cervical cancer patients.
- ACRONYMGREEN LIGHT
- hypothesisICG alone without being absorbed to albumin can be used for near-infrared fluorescence SLNB in cervical cancer patients.
- Healt Condition(s) or Problem(s) studiedCervix cancer
- Inclusion criteriaCervical cancer patients planned to undergo a lymphadenectomy.
- 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 participants18
- InterventionsStandard lymphadenectomy will be performed. Before median laparotomy, the near-infrared dye ICG:HSA of ICG alone will be injected peritumorally around the cervix and lymphatic pathways and lymph nodes will be visualized non-invasively 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 not regarded standard of care, the technique can potentially be implemented in cervical cancer patients. Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes. In this study, randomisation will be performed between ICG:HSA and ICG alone.
- Main changes (audit trail)
- RECORD27-apr-2011 - 6-mei-2011


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