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Sentinel lymph node detection in vulvar cancer.


- candidate number6382
- NTR NumberNTR1983
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2009
- Secondary IDsBICG06UMCG-NIRF/NL26982.042.09 UMCG/ CCMO
- Public TitleSentinel lymph node detection in vulvar cancer.
- Scientific TitleEvaluation of near-infrared fluorescence (NIRF) imaging for sentinel lymph node (SLN) detection in squamous cell carcinoma of the vulva: a feasibility study.
- ACRONYMN/A
- hypothesisSentinel lymph node detection with fluorescent probes.
- Healt Condition(s) or Problem(s) studiedVulvar cancer
- Inclusion criteria1. Female > 21 years of age;
2. Unifocal squamous cell carcinoma of the vulva proven by histology on a biopsy, depth of invasion > 1mm, tumour size < 4mm, no suspicious inguinal nodes on CT scan or palpation.
- Exclusion criteria1. Pregnancy;
2. Renal, cardiac or pulmonary failure (ASA III-IV);
3. Previous or present hyperthyreoidism;
4. Iodine allergy or previoius anaphylactic reactions.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate
- Target number of participants10
- InterventionsPatients with unifocal squamous cell carcinoma of the vulva stage I or II, smaller than 4 cm undergoing surgery, combined with a sentinel lymph node procedure, will receive an peritumoural injection with indocyanine green (ICG) prior to surgery, but after administration of full anaesthesia. During the operative procedure NIRF imaging for detection of the SLN (i.e. ICG accumulation) will take place.
- Primary outcomeIdentification of sentinel lymph nodes within the allocated procedure (usually 15-30 minutes).
- Secondary outcomeN/A
- TimepointsSurgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. G.M. Dam, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThis project consists on the realization followed by the clinical validation of a diagnostic procedure dedicated to the identification and localization of sentinel lymph nodes (SLN) in the case of squamous cell carcinoma of the vulva. An intra-operative near-infrared fluorescence (NIRF) imaging camera and the use of a NIRF optical contrast agent will be evaluated for its feasibility to detect the sentinel lymph node in patients with squamous cell carcinoma of the vulva. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The current golden standard consists of the use of a radiocolloid and a blue dye. This requires an peritumoural intradermal injection on the day prior to surgery. The injection of the optical contrast agent for the use of the NIRF-camera takes place during surgery, under full anaesthesia. The end-goal of this intra-operative imaging procedure, therefore, is to significantly reduce the psychological stress on the patient. Gynecologic oncologists, surgeons and fundamental physics applied to medical imaging researchers are involved in this project.
- Main changes (audit trail)
- RECORD31-aug-2009 - 12-okt-2009


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