Sentinel node mapping for bladder cancer is possible using the hybrid tracer ICG-99mTc-nanocolloid
ID
Bron
Verkorte titel
Aandoening
Bladder cancer; Bladder carcinoma;
Ondersteuning
NWO-STW-VIDI (Grant No. STW BGT11272)
ERC-starting Grant (Grant No. 2012-306890)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Evaluate the accuracy of the sentinel node biopsy procedure for nodal staging in patients with non-metastatic (cN0M0) muscle-invasive bladder cancer.
Achtergrond van het onderzoek
Radical cystectomy combined with an extended pelvic lymph node dissection is considered the gold standard for staging in non-metastatic muscle-invasive bladder cancer. The sentinel node procedure is an alternative method to locally stage bladder cancer. In this study we aim to evaluate the sentinel node procedure in bladder cancer patients who are scheduled for radical cystectomy and extended pelvic lymph node dissection.
Doel van het onderzoek
Sentinel node mapping for bladder cancer is possible using the hybrid tracer ICG-99mTc-nanocolloid
Onderzoeksopzet
Injection (t=0); Preoperative imaging (t=15 min, and t=2 hours); Intraoperative imaging (t=>3hours)
Onderzoeksproduct en/of interventie
On the day before surgery (approximately 18 hours) patients will receive 4-6 transurethral injections with a total of 2mL hybrid tracer (240MBq) around the tumor (in case of a solitary lesion) or divided over the bladder (in case of multiple tumors). In both cases the hybrid tracer is injected into the detrusor muscle of the bladder under cystoscopy guidance using an endoscopic needle.
After the injection lymphoscintigraphy will be performed at 15 min and 2 hours, followed by SPECT/CT imaging at 2 hours.
Intraoperatively sentinel nodes will be identified via combined radio- and fluorescence guidance. For radioguidance, a (laparoscopic) gamma probe will be used. Fluorescence imaging during the operation will be performed using a fluorescence camera for open surgery or for laparoscopic surgery. Additionally, during robot-assisted procedures, the da Vinci SI integrated fluorescence camera (Firefly) will be used. The declipseSPECT navigation system will be used to locate the sentinel nodes intraoperatively.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients >18 years;
- Histopathologically proven bladder cancer;
- Patients are cN0M0;
- Patients scheduled for radical cystectomy with or without neo-adjuvant chemotherapy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Preoperatively known distant metastases (M1);
- Clinically tumor-positive nodes;
- Patients scheduled for brachytherapy of the bladder;
- Previous radiation therapy of the pelvis;
- Previous pelvic surgery for other reasons such as urologic and gynecologic malignancies (exception: trans-urethral operations like e.g. transurethral bladder resection).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5088 |
NTR-old | NTR5220 |
Ander register | : M14HSN |