Plain-English translation of NCT04511078 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing , a special dye designed to help surgeons see cancer more clearly during head and neck surgery. The medication is given as an infusion before surgery and binds to cancer cells, making them glow under special lighting so surgeons can identify exactly where the tumor ends and healthy tissue begins. This could help surgeons remove cancer more completely while avoiding unnecessary removal of healthy tissue.
Currently, surgeons struggle to see the exact edges of head and neck tumors during surgery, which means about 40% of patients end up with incomplete tumor removal. The standard methods—feeling the tumor, looking at it, and testing small tissue samples—are not reliable, especially for tumors near bone, in deep areas, or in previously treated tissue. This medication aims to solve that problem by making cancer cells visible in real time.
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You would receive an infusion of the medication over about one hour before your scheduled surgery. The medication will circulate through your body and bind to any cancer cells present. During your surgery, the surgeon will use special lighting to see where the medication has attached, helping them identify tumor margins and plan the most complete resection. Your participation essentially involves receiving the medication as part of your standard surgical care, with the added benefit of improved visualization during the procedure.
AI-generated summary from trial data · Jul 3, 2026 · Not medical advice
United States
Phase
Testing effectiveness
Sponsor
University of Alabama at Birmingham
Enrollment target
~25 participants
Started
April 2021
Primary completion
December 2030
Age range
18 Years and older
Last updated on clinicaltrials.gov in December 2025.
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Central contact
Destiny Talley, RN
University of Alabama at Birmingham
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