A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Not Recruiting

Trial ID: NCT04420689

Purpose

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.

Official Title

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

Eligibility


Inclusion Criteria:

   1. A neoplasm located in the head and neck.

   2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck
   dissection.

   3. Can understand and is willing to sign a written informed consent document.

   4. ≥18 years of age.

   5. Life expectancy of at least 6 months.

   6. Normal liver and kidney functions.

   7. 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.

   8. Plans to undergo head and neck surgery.

Exclusion Criteria:

   1. Prior radiation or chemotherapy for any prior head and neck neoplasm.

   2. Open surgery in the ipsilateral head and neck within 1 year.

   3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary
   events and/or heart failure within 1 year.

   4. Current evidence of renal disease.

   5. Pregnant or breastfeeding.

   6. Unresolved acute toxicity from prior anti-cancer therapy.

   7. History of fluorescein allergy.

   8. Any other criteria deemed by the Principal Investigator that may prevent the patient
   from successfully completing the trial.

Intervention(s):

drug: ALM-488

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Yi
650-242-2666

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