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Intraoperatieve fluorescente beeldvorming van hypofyse adenomen met indocyanine groen.


- candidate number13424
- NTR NumberNTR3656
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2012
- Secondary IDsP10.001 METC LUMC
- Public TitleIntraoperatieve fluorescente beeldvorming van hypofyse adenomen met indocyanine groen.
- Scientific TitleReal-time intraoperative fluorescence imaging of pitiutary adenomas using Indocyanine green.
- ACRONYMGREEN LIGHT
- hypothesisNear-infrared fluorescent imaging using indocyanine green can be used to detect pituitary adenomas during pituitary surgery.
- Healt Condition(s) or Problem(s) studiedPituitary adenomas
- Inclusion criteria1. Patients diagnoses with pitiutary adenoma, planned for resection;
2. Age between 18 and 80 years old.
- Exclusion criteria1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin;
2. Pregnancy;
3. Hyperthyroidism;
4. Severe renal impairement;
5. 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
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2012
- planned closingdate1-mei-2014
- Target number of participants20
- InterventionsStandard pituitary adenoma resection will be performed. Just before the actual resection, indocyanine green will be injected intravenously to identify the pituiraty adenoma using NIR fluorenscence.
- Primary outcomeIntra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of indocyanine green during operation.
- Secondary outcomeTumor-to-background signal of the identified adenomas.
- 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 pituitary surgery is the intraoperative adenoma detection. Near-infrared fluorescent (NIRF) imaging is a recently developed method to possibly visualize pituitary adenomas during surgery. Standard pituitary adenoma resection will be performed. Just before the actual resection, the near-infrared dye indocyanine green will be injected i.v. and the pituitary adenomas will be visualized non-invasively and using our experimental camerasystem.
- Main changes (audit trail)
- RECORD9-okt-2012 - 22-okt-2012


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