Actively Recruiting
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Led by Erasmus Medical Center · Updated on 2025-02-26
28
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
CONDITIONS
Official Title
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor
- 18 years of age or older
- Written informed consent given according to ICH/GCP, and national/local regulations
- Screening ECG and clinical laboratory test results within normal limits, or abnormalities considered clinically insignificant
You will not qualify if you...
- Previous surgery, chemotherapy, or radiotherapy to the oral cavity
- History of a clinically significant allergy or anaphylactic reactions to any components of the agent
- Pregnant or breastfeeding patients, or lack of effective contraception in male or female patients with reproductive potential
- Renal insufficiency (eGFR less than 60)
- History of kidney transplantation
- Immunocompromised patients unable to respond normally to infection due to disease or medications
- Any condition that may jeopardize the patient's well-being or study objectives according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
S
Stijn Keereweer, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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