Guided by light: Optimizing surgical excision of oral cancer using real-time fluorescence imaging
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Registration Number
- NL-OMON24301
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 29
1) Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
2) = 18 years of age;
3) Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
4) Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits, they are considered to be clinically insignificant;
5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
1) Previous surgery, chemotherapy or radiotherapy to the oral cavity;
2) History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
3) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
4) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean tumor-to-background ratio (TBR)<br>2. Rate of adequate (i.e. >5mm clear) tumor resection margins
- Secondary Outcome Measures
Name Time Method 1. Sensitivity, specificity, positive and negative predictive values<br>2. Co-localization of FLI with immunohistochemistry on pathology slides<br>3. Percentage of extra tissue resection based on FLI-driven frozen sections<br>4. Operation time<br>5. FLI of lymph node metastases after neck dissection