Glow-in-the-Dark dye could help surgeons avoid nerve damage
NCT ID NCT06227585
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed trial tested a dye called bevonescein (ALM-488) and a special imaging system (REVEAL 475) to make nerves glow during head and neck surgery. 155 patients received the dye before surgery, and surgeons used the system to see nerves more clearly. The goal was to help surgeons avoid accidentally damaging nerves, which can cause problems like facial weakness or voice changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bevonescein (ALM-488) dye
- What this could lead to
- If successful, this could help surgeons avoid accidentally cutting nerves during head and neck surgery, potentially reducing complications like facial paralysis or voice changes.
- What could go wrong
- This is an early combined Phase 2/3 trial with 155 participants, so results may not apply to all surgeries. The dye and device may not improve nerve visibility enough to change surgical outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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155 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA 1. Must be a minimum of 16 years of age. 2. Must be planning to undergo surgery in the Head and Neck. 3. The study participant's primary surgical treatment is parotidectomy or thyroidectomy/ parathyroidectomy (unilateral or bilateral) or cervical neck dissection. 4. Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. 5. Willing and able to comply with all study procedures. 6. Sexually active patients must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving bevonescein. 7. Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had bilateral tubal ligation at least 1 year prior to screening, or who have had total hysterectomy. EXCLUSION CRITERIA 1. The patient has a history of prior surgery and/or radiation to the intended surgical site. 2. The patient has abnormal cardiac rhythm not controlled with medication. 3. The patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \< 60 mL/min. 4. The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.\* 5. The patient has unresolved acute toxicity from prior anti-cancer therapy grade 2 or higher, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Alopecia, neuropathy ≤ Grade 2, as well as other nonacute and stable anti-cancer therapy toxicities are acceptable. 6. The patient has a history of fluorescein allergy. 7. The patient has a history of drug-related anaphylactic or severe allergic reactions. 8. Presence or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects. 9. Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction (MI) or cerebrovascular accident (CVA). 10. Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study. 11. Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study. 12. Use of any Investigational Product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. * In patients with confirmed Gilbert Syndrome, total serum bilirubin may be elevated up to 3x the institution's normal laboratory limits.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alume Biosciences
La Jolla, California, 92037, United States
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