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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