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)


Laparoscopische Intra-operatieve fluorescente beeldvorming van oogmelanoom lever metastasen.


- candidate number14425
- NTR NumberNTR3869
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2013
- Secondary IDsP10.001 METC LUMC
- Public TitleLaparoscopische Intra-operatieve fluorescente beeldvorming van oogmelanoom lever metastasen.
- Scientific TitleLaparoscopic Near-Infrared Fluorescence Imaging of Hepatic Uveal Melanoma Metastases.
- ACRONYMGREEN LIGHT
- hypothesisLaparoscopic Fluorescent near-infrared imaging using ICG can accurately detect liver metastases from uveal melanoma intra operatively.
- Healt Condition(s) or Problem(s) studiedHepatic Uveal Melanoma Metastases
- Inclusion criteria1. Patients diagnosed with uveal melanoma liver metastasis 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-sep-2012
- planned closingdate1-sep-2013
- Target number of participants15
- InterventionsICG will be administered 24hours before surgery. During laparoscopic surgery, liver metastases will be visualised using near-infrared fluorescence imaging and standard liver resection will be performed.
- Primary outcomeFeasiility of Intra-operative identification of liver metastases.
- Secondary outcomeIdentification rate; defined as the number of tumours that were identified with the fluorescent signal of ICG during operation, compared with the number of microscopically Tumor 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
- 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)
- PublicationsN/A
- Brief summaryOne of the main challenges in liver surgery for uveal liver metastasis 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. The near-infrared dye ICG will be injected i.v. and liver tumors will be visualized using a laparoscopic NIRF imaging system.
- Main changes (audit trail)
- RECORD21-feb-2013 - 2-mrt-2013


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