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Intra-operatieve fluorescente beeldvorming van bijschildklieren.


- candidate number12264
- NTR NumberNTR3403
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2012
- Secondary IDsP10.001  METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van bijschildklieren.
- Scientific TitleIntraoperative Near-Infrared Fluorescence Imaging of Parathyroid Adenomas using Low-Dose Methylene Blue.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can assess parathyroid adenoma perfusion by methylene blue.
- Healt Condition(s) or Problem(s) studiedParathyroid adenoma, Near-infrared fluorescence imaging, Methylene blue
- 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
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-aug-2012
- Target number of participants15
- InterventionsStandard parathyroid adenoma resectino will be performed. 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 possibly visualize parathyroid adenomas during surgery. Standard parathyroid adenoma resection will be performed. After mobilization, the near-infrared dye methylene blue will be injected i.v. and the parathyroid adenomas 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)
- RECORD19-apr-2012 - 26-apr-2012


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