Multicenter study evaluating the hybrid approach using a novel fluorescence camera - Identifying the value of intraoperative fluorescence imaging during sentinel node biopsy procedures
Phase 2
- Conditions
- sentinel node biopsyschildwachtklierprocedure
- Registration Number
- NL-OMON47277
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 125
Inclusion Criteria
- Patients >= 18 years;
- Patients with a primary or recurrent breast cancer;
- Patient with a primary melanoma;
- Patients with a primary head-and-neck malignancy;
- Patient with a primary or recurrent urological malignancy;
- Patients with a primary or recurrent gynecological malignancy;
- Patients present with negative regional lymph nodes (exception: vulvar and penile cancer: N1 patients are also eligible);
- Patients that will undergo a sentinel node biopsy procedure.
Exclusion Criteria
- History of iodine allergy;
- Hyperthyroid or thyroidal adenoma;
- Kidney insufficiency;
- Pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Determine the value of fluorescence imaging-guided surgery under ambient<br /><br>light conditions for the identification of hybrid tracer-containing SNs as seen<br /><br>on preoperative imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Determine the value (accuracy) of fluorescence imaging-assisted SN<br /><br>identification to the conventional radioguided approach;<br /><br>- Determine the value of fluorescence imaging-assisted SN identification to the<br /><br>conventional blue dye-based approach;<br /><br>- Evaluation of (post-operative) complications within 90 days after surgery<br /><br>(Clavien-Dindo score);<br /><br>- Evaluation of follow-up (local recurrence after SN biopsy).</p><br>