|- candidate number||22210|
|- NTR Number||NTR5220|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2015|
|- Secondary IDs||M14HSN |
|- Public Title||Bladder cancer sentinel node mapping using ICG-99mTc-nanocolloid|
|- Scientific Title||Sentinel node mapping for bladder cancer using the hybrid tracer ICG-99mTc-nanocolloid|
|- ACRONYM||Hybrid tracer for bladder cancer sentinel node biopsy|
|- hypothesis||Sentinel node mapping for bladder cancer is possible using the hybrid tracer ICG-99mTc-nanocolloid|
|- Healt Condition(s) or Problem(s) studied||Bladder carinoma|
|- 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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jul-2015|
|- planned closingdate||1-jul-2017|
|- Target number of participants||30|
|- Interventions||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.
|- 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).
|- Timepoints||Injection (t=0); Preoperative imaging (t=15 min, and t=2 hours); Intraoperative imaging (t=>3hours)|
|- Trial web site||AVL-NK intranet --> TRION|
|- CONTACT FOR PUBLIC QUERIES|| Bas van Rijn|
|- CONTACT for SCIENTIFIC QUERIES|| FWB van Leeuwen|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) |
(Source(s) of Monetary or Material Support)
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), NWO-STW-VIDI (Grant No. STW BGT11272) , ERC-starting Grant (Grant No. 2012-306890)|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||18-mei-2015 - 29-jul-2015|