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)


Optimalisatie van intra-operatieve fluorescente beeldvorming van bijschildklieren.


- candidate number15773
- NTR NumberNTR4279
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2013
- Secondary IDsP10.001 METC Leiden
- Public TitleOptimalisatie van intra-operatieve fluorescente beeldvorming van bijschildklieren.
- Scientific TitleOptimization of Intraoperative Near-Infrared Fluorescence Imaging of Parathyroid Adenomas using Low-Dose Methylene Blue.
- ACRONYMGREEN LIGHT
- hypothesisDelayed fluorescent near-infrared imaging can improve parathyroid adenoma identification using methylene blue.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Patients diagnosed with primary hyperparathyroidism;
2. Age between 18 and 80.
- Exclusion criteria1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-jul-2014
- Target number of participants30
- InterventionsStandard parathyroid adenoma resectino will be performed. Just before sugery of after opening the neck region, methylene blue will be injected intravenously to identify the parathyroid adenoma using NIR fluorenscence.
- Primary outcomeIntra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of methylene blue 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 parathyroid surgery for primary hyperparathyroidism is the intraoperative adenoma detection. Especially intra-operative detection of small adnomas has proven to be very difficult. Near-infrared fluorescent (NIRF) imaging is a recently developed method to visualize vital structures and tumors. Previous research has shown that intraopertaive visualization of parathyroid adenomas using methylene blue is feasibile. The aim of this study is to improve visualization bye comparing early and delayed imaging protocols after iv administration of Methylene Blue.
- Main changes (audit trail)
- RECORD27-nov-2013 - 6-dec-2013


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