CompletedPhase 1/2

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

United States27 participantsStarted 2020-06-18

Plain-language summary

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. A neoplasm located in the head and neck.
✓. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
✓. Can understand and is willing to sign a written informed consent document.
✓. ≥18 years of age.
✓. Life expectancy of at least 6 months.
✓. Normal liver and kidney functions.
✓. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
✓. Plans to undergo head and neck surgery.

✕. Prior radiation or chemotherapy for any prior head and neck neoplasm.
✕. Open surgery in the ipsilateral head and neck within 1 year.
✕. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
✕. Current evidence of renal disease.
✕. Pregnant or breastfeeding.
✕. Unresolved acute toxicity from prior anti-cancer therapy.
✕. History of fluorescein allergy.
✕. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.

Safety - The Number of Patients With ALM-488 Related Adverse Events

Timeframe: 28 (+5) days

NCT IDNCT04420689

SponsorAlume Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-25

Results submitted2022-08-26

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. A neoplasm located in the head and neck.
✓. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
✓. Can understand and is willing to sign a written informed consent document.
✓. ≥18 years of age.
✓. Life expectancy of at least 6 months.
✓. Normal liver and kidney functions.
✓. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
✓. Plans to undergo head and neck surgery.

✕. Prior radiation or chemotherapy for any prior head and neck neoplasm.
✕. Open surgery in the ipsilateral head and neck within 1 year.
✕. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
✕. Current evidence of renal disease.
✕. Pregnant or breastfeeding.
✕. Unresolved acute toxicity from prior anti-cancer therapy.
✕. History of fluorescein allergy.
✕. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.