Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
- Conditions
- Squamous Cell Carcinoma of the Oral CavityTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2019-003416-30-NL
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 31
1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
2. Patients = 18 years of age;
3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31
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. Patients with renal insufficiency (eGFR<60);
5. Patients with a previous kidney transplantation in the medical history;
6. Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);
7. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
8. Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient’s well-being or the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve adequate resection of oral cancer using fluorescent imaging technology:<br>1. To determine the recommended dose for the highest tumor-to-background ratio (TBR) of at least >2.0 using cRGD-ZW800-1 in oral cancer;<br>2. To increase the rate of adequate (i.e. >5mm clear) tumor resection margins;Secondary Objective: 1. To determine the recommended dosage of cRGD-ZW800-1 for intraoperative imaging of oral cancer.<br>2. To determine the sensitivity, specificity, positive and negative predictive values of FLI<br>3. To-determine colocalization of FLI with immunochemistry on pathology slides<br>4. To determine the percentage of extra tissue resection based on FLI-driven frozen sections<br>5. To determine if FLI significantly increases operation time<br>6. To determine if lymph node metastases can be identified using FLI;Primary end point(s): Rate of adequate (i.e. >5mm clear) tumor resection margins.;Timepoint(s) of evaluation of this end point: Surgery and follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: Surgery and follow-up