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Intraoperatieve fluorescente beeldvorming van borsttumoren.


- candidate number14018
- NTR NumberNTR3713
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2012
- Secondary IDsP10.001 METC LUMC
- Public TitleIntraoperatieve fluorescente beeldvorming van borsttumoren.
- Scientific TitleIntraoperative fluorescent imaging of breast cancer.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can accurately detect breast cancer using Methylene Blue.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaPatients diagnosed with breast cancer eligible to undergo a resection.
- Exclusion criteria1. Patients using SSRI's, SNRI's of TCA's;
2. Allergy to methyleen blue, history of severe renal impairment or G6PD-deficiency;
3. Patient pregnant or lactating.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate1-jul-2013
- Target number of participants40
- InterventionsStandard breast conserving surgery or ablation procedure will be performed. During surgery or 4 hours before surgery, the near-infrared dye Methylene blue (MB) will be injected and the breast carcinoma will be visualized non-invasively using our experimental camerasystem.
- Primary outcomePrimary outcome parameter is the number of identified breast tumors.
- Secondary outcomeSecundary parameters are the tumor-to-background ratios measured during surgery and during pathological analysis.
- 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 summaryBreast cancer is the most common type of cancer in women. Irradical resections in breast cancer occurs in up to 20% of the patients. To reduce the number of patients with positive resection margins, near-infrared fluorescence imaging can be very usefull.
The aim of this study is to intraoperatively identify breast cancer using methylene blue and near-infrared fluorescence.
- Main changes (audit trail)
- RECORD21-nov-2012 - 1-dec-2012


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