Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04191460

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

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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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Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer | DecenTrialz