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

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alume Biosciences, Inc.

Criteria

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.