The use of indocyanine green for accurate sentinel node detection and removal in a group of high-risk nodal metastasis prostate cancer patients To optimize and improve the sentinel node procedure in men with prostate cancer
Phase 2
- Conditions
- prostate cancerprostate carcinoma1003859710036958
- Registration Number
- NL-OMON44119
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion Criteria
* Histologically proven prostate cancer
* Increased risk of nodal metastases according to the MSKCC nomogram (> 10%)
* Scheduled for surgical (laparoscopic) 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>Primary objective: Further validation of the sentinel node procedure for<br /><br>prostate cancer via ultrasound guided transrectal ICG-99mTc-nanocolloid<br /><br>injection surrounding the tumor tumor location will be determined following<br /><br>diffusion weighted MR imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective: Improving the ICG-99mTc-nanocolloid injection; an<br /><br>ultrasound guided intratumoral injection of ICG-99mTc-nanocolloid<br /><br>will be performed instead of a transrectal injection<br /><br>Tertiary objective: Improving the identification of lymphatic drainage patterns<br /><br>through a preoperative intraprostatic injection of fluorescein at the start of<br /><br>the surgical procedure. This fluorescein injection will be given to patients<br /><br>who<br /><br>also received an intratumoral injection of ICG-99mTc-nanocolloid in<br /><br>the morning (a total of 20 patients will be included that have already been<br /><br>included under the secondary study objective).<br /><br>Quaternary objective: Fluorescence imaging of paraffin-embedded prostate<br /><br>samples<br /><br>allows the determination of the tumor location with regard to the location of<br /><br>the ICG-99mTc-nanocolloid deposits</p><br>