Intra-operative evaluation of a novel FLUorescENt C-mEt tracer in penile and tongue cancer
Phase 2
Recruiting
- Conditions
- penile carcinoma and tongue carcinoma10027655
- Registration Number
- NL-OMON48118
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
• Age >= 18 years at time of study entry.
• >= T1 penile or tongue squamous cell cancer
• Scheduled for surgical primary tumour resection
Exclusion Criteria
• Pregnant woman
• Abstaining from usage of two forms of barrier contraceptive or actively
planning pregnancy within 90 days.
• Severe kidney insufficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Intraoperative visualization of primary penile or tongue tumours using a<br /><br>dedicated clinical fluorescence camera. The in vivo detected fluorescence<br /><br>signal will be correlated to ex vivo measurements and pathological assessment<br /><br>of the excised tissue. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Detection and visualization of lymph node metastases in penile and tongue<br /><br>tumour patients<br /><br>- Identification of dysplasia or carcinoma in situ in penile and tongue tumours.<br /><br>- Toxicity by CTCAE-NCI V4</p><br>