Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Realtime Fluorescence Imaging

Phase 1/2

Not yet recruiting

• Conditions: Oral cancer

• Registration Number: 2024-512824-13-01
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

To improve adequate resection of oral cancer using fluorescent imaging

technology:

1. To determine the recommended dose for the highest tumor-tobackground

ratio (TBR) of at least >1.5 using cRGD-ZW800-1 in oral cancer;

2. To increase the rate of adequate (i.e. >5mm clear) tumor resection margins

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;

Patients ≥ 18 years of age;

Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

Previous surgery, chemotherapy or radiotherapy to the oral cavity;

History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.

Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;

Patients with renal insufficiency (eGFR<60);

Patients with a previous kidney transplantation in the medical history;

Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);

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;

Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient's wellbeing or the study objectives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adequate (i.e. >5mm clear) tumor resection margins.		Rate of adequate (i.e. >5mm clear) tumor resection margins.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive values		Sensitivity, specificity, positive and negative predictive values
Co-localization of FLI with immunohistochemistry on pathology slides		Co-localization of FLI with immunohistochemistry on pathology slides
Percentage of extra tissue resection based on FLI-driven frozen sections		Percentage of extra tissue resection based on FLI-driven frozen sections
Operation time		Operation time
FLI of lymph node metastases after neck dissection		FLI of lymph node metastases after neck dissection

Trial Locations

Locations (1)

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

🇳🇱Rotterdam, Netherlands

Stijn Keereweer

Site contact

0107041357

s.keereweer@erasmusmc.nl