Glow-in-the-Dark dye could save voices in thyroid surgery
NCT ID NCT07631650
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 6 times
Summary
This phase 2 trial tests a dye called bevonescein that makes nerves glow during thyroid surgery, helping surgeons see and avoid them. Forty adults having thyroid removal will receive the dye before surgery. The main goal is to see if it improves voice outcomes by reducing nerve injury.
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) infusion
- What this could lead to
- If it works, this dye could help surgeons avoid damaging nerves during thyroid surgery, potentially preserving patients' voice quality.
- What could go wrong
- This is an early phase 2 trial with only 40 participants, so results may not apply to everyone. The dye's effectiveness and safety are still being tested.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 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. Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm 2. Must be a minimum of 18 years old or older 3. Must be able to give documented informed consent to participate in this study 4. Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator 5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. 6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. 7. Willing and able to comply with all study procedures Exclusion Criteria: 1. Previous history of surgery and/or radiation to the head, neck, or shoulder 2. Abnormal cardiac rhythm not controlled with medication 3. The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator 4. Presence or history of any hypersensitivity to bevonescein (or fluorescein) or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects 5. 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) 6. 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 7. Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments 8. The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UMPC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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