Prospective randomized multicenter comparison of indocyanine green (ICG)-99mTc-nanocolloid vs. 99mTc-nanocolloid plus an intraoperative injection of ICG for the detection and surgical resection of the sentinel nodes in patients with prostate cancer
Phase 2
- Conditions
- prostate cancerprostate carcinoma1003859710036958
- Registration Number
- NL-OMON45195
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
• Histologically proven prostate cancer;
• Patients are clinically node negative and metastases negative (N0, M0);
• Increased risk of nodal metastases according to the Briganti nomogram (> 7%);
• Scheduled for surgical (laparoscopic or robotic) prostatectomy including nodal dissection.
Exclusion Criteria
• History of iodine allergy;
• Hyperthyroid or thyroidal adenoma;
• Kidney insufficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of positive patients (as determined following histopathological<br /><br>analysis of the excised nodes).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Collection of the below summarized information will provide us an answer to the<br /><br>following secondary endpoints:<br /><br>1. What is the role of preoperative SPECT/CT for the identification of SNs<br /><br>draining from the prostate?<br /><br>2. Is there a difference between ICG-99mTc-nanocolloid and free ICG in the<br /><br>optical identification of SNs of the prostate?</p><br>