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Intra-operatieve fluorescente beeldvorming van levertumoren.


- candidate number7758
- NTR NumberNTR2213
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2010
- Secondary IDsP10.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van levertumoren.
- Scientific TitleIntra-operative identification of colorectal liver metastasis or hepatocellular carcinoma using indocyanin green nearinfrared fluorescence.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging using ICG can accurately detect liver tumors intra operatively.
- Healt Condition(s) or Problem(s) studiedHepatocellular carcinoma, Colorectal liver metastasis, Liver tumor
- Inclusion criteria1. Patients diagnosed with colorectal cancer liver metastasis or hepatocellular carcinoma that are eligible for resection;
2. Age between 18 and 80 years old.
- Exclusion criteria1. No history of allergy to iodine, shellfish, indocyanine green, human serum albumin and/or history of hyperthyroidism or severe renal impairment;
2. Patient pregnant or lactating.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-jul-2010
- Target number of participants12
- InterventionsStandard liver resection will be performed. After mobilization, the near-infrared dye ICG will be injected i.v. and liver tumors will be visualized non-invasively and using our experimental camerasystem.
- Primary outcomeIntra-operative identification rate, defined as the number of tumours that were identified with the fluorescent signal of ICG during operation, compared with the number of microscopically confirmed tumours.
- Secondary outcomeTumor to background ratio between different doses of ICG injected and different time intervals injected.
- 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)
Center for Translational Molecular Medicine (CTMM)
- PublicationsN/A
- Brief summaryOne of the main challenges in liver surgery for colorectal cancer liver metastasis and hepatocellular carcinomas is intraoperative tumor detection. Especially intra-operative detection of small tumors has proven to be very difficult. Near-infrared fluorescent (NIRF) imaging is a recently developed method to visualize tumor tissue during surgery. Standard liver resection will be performed. After mobilization, the near-infrared dye ICG will be injected i.v. and liver tumors will be visualized non-invasively and using our experimental camerasystem. Our experimental camera system has been validated in large animal models.
- Main changes (audit trail)
- RECORD12-feb-2010 - 28-apr-2011


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