Sentinel lymph node detection with fluorescent probes.
ID
Bron
Verkorte titel
Aandoening
vulvar cancer
vulvacarcinoom
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Identification of sentinel lymph nodes within the allocated procedure (usually 15-30 minutes).
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
Sentinel lymph node detection with fluorescent probes.
Onderzoeksopzet
Surgery.
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Wetenschappelijk
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy;
2. Renal, cardiac or pulmonary failure (ASA III-IV);
3. Previous or present hyperthyreoidism;
4. Iodine allergy or previoius anaphylactic reactions.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1870 |
NTR-old | NTR1983 |
Ander register | UMCG/ CCMO : BICG06UMCG-NIRF/NL26982.042.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |