Guided by light: Optimizing surgical excision of oral cancer using real-time fluorescence imaging

Phase 2

Recruiting

Conditions: cancer
squamous cell carcinoma of the oral cavity
10027656

Registration Number: NL-OMON49733

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

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.

Exclusion Criteria

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 to the patient's wellbeing
or the study objectives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To determine the TBR of cRGD-ZW800-1 in patients with oral cancer;<br /><br>2) To determine if using FLI can increase the rate of adequate (i.e. >5mm<br /><br>clear) tumor resection margins.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To determine the recommended dosage of cRGD-ZW800-1 for intraoperative<br /><br>imaging of oral cancer.<br /><br>2) To determine the sensitivity, specificity, positive and negative predictive<br /><br>values of FLI<br /><br>3) To-determine colocalization of FLI with immunochemistry on pathology slides<br /><br>4) To determine the percentage of extra tissue resection based on FLI-driven<br /><br>frozen sections<br /><br>5) To determine if FLI significantly increases operation time<br /><br>6) To determine if lymph node metastases can be identified using FLI</p><br>