RecruitingPhase 2NCT04191460

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

Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging


Sponsor

Erasmus Medical Center

Enrollment

28 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new fluorescent dye (cRGD-ZW800-1) that is injected before surgery to help surgeons see cancer tissue more clearly during mouth cancer removal. The dye lights up cancer cells under special imaging, potentially allowing surgeons to more precisely remove all the cancer while preserving healthy tissue. **You may be eligible if...** - You are 18 or older - You have biopsy-proven squamous cell carcinoma (cancer) of the oral cavity (mouth) - You are scheduled for surgery to remove the primary tumor - Your ECG and standard lab tests are within normal limits (or minor abnormalities that are deemed safe) **You may NOT be eligible if...** - You are not a surgical candidate for your mouth cancer - You have serious heart, liver, or kidney problems that could affect dye metabolism or safety - You are pregnant or breastfeeding - You have a known allergy to the dye or its components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcRGD-ZW800-1.

Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery


Locations(1)

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

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NCT04191460


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