Bladder cancer sentinel node mapping using ICG-99mTc-nanocolloid

• Conditions: Bladder cancer; Bladder carcinoma

• Registration Number: NL-OMON21640
• Lead Sponsor: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients >18 years;

- Histopathologically proven bladder cancer;

Exclusion Criteria

- Preoperatively known distant metastases (M1);

- Clinically tumor-positive nodes;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the accuracy of the sentinel node biopsy procedure for nodal staging in patients with non-metastatic (cN0M0) muscle-invasive bladder cancer.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of the feasibility of sentinel node mapping in bladder cancer patients using the hybrid tracer (ICG-99mTc-nanocolloid);<br /><br>2. Evaluation of intraoperative fluorescence detection of the SNs via fluorescence imaging;<br /><br>3. Evaluation of the feasibility of sentinel node localization via intraoperative (SPECT/CT-based and freehandSPECT).