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ID
Source
Brief title
Health condition
Bladder cancer; Bladder carcinoma;
Sponsors and support
NWO-STW-VIDI (Grant No. STW BGT11272)
ERC-starting Grant (Grant No. 2012-306890)
Intervention
Outcome measures
Primary outcome
Evaluate the accuracy of the sentinel node biopsy procedure for nodal staging in patients with non-metastatic (cN0M0) muscle-invasive bladder cancer.
Secondary outcome
1. Evaluation of the feasibility of sentinel node mapping in bladder cancer patients using the hybrid tracer (ICG-99mTc-nanocolloid);
2. Evaluation of intraoperative fluorescence detection of the SNs via fluorescence imaging;
3. Evaluation of the feasibility of sentinel node localization via intraoperative (SPECT/CT-based and freehandSPECT).
Background summary
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.
Study objective
Sentinel node mapping for bladder cancer is possible using the hybrid tracer ICG-99mTc-nanocolloid
Study design
Injection (t=0); Preoperative imaging (t=15 min, and t=2 hours); Intraoperative imaging (t=>3hours)
Intervention
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.
Inclusion criteria
- Patients >18 years;
- Histopathologically proven bladder cancer;
- Patients are cN0M0;
- Patients scheduled for radical cystectomy with or without neo-adjuvant chemotherapy.
Exclusion criteria
- 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL5088 |
| NTR-old | NTR5220 |
| Other | : M14HSN |