Sentinel node biopsy for bladder cancer using the hybrid tracer
- Conditions
- Bladder cancerBladder carcinoma10004994
- Registration Number
- NL-OMON41181
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients >18 years with clinically localized bladder cancer
Patients with proven histological-pathological bladder cancer
Patients scheduled for brachytherapy or radical cystectomy with or without neo-adjuvant chemotherapy
Patients with cN0 lymph node status
Exclusion Criteria
Patients with preoperatively known distant metastases (M1);
Patients with clinically tumor positive nodes;
Previous radiation therapy of the pelvis;
Previous pelvic lymphadenectomy for other reasons such as urologic and gynecologic malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the accuracy of the SN biopsy for nodal staging in patients with<br /><br>muscle invasive bladder cancer. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Evaluation of intraoperative fluorescence detection of the SNs;<br /><br>• Feasibility of intraoperative SPECT/CT-based navigation using the<br /><br>declipseSPECT system;<br /><br>• Feasibility of freehand SPECT-based navigation to the SN using the<br /><br>declipseSPECT navigation system. </p><br>