Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

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

Details

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

Keywords

Parotid Neoplasm Thyroid Neoplasms Head and Neck Neoplasms Surgery Nerve Injury Imaging Nerve Fluorescence Real-time Intraoperative Highlighting Neoplasms Parotid Neoplasms ALM-488

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alume Biosciences, Inc.
ID
NCT04420689
Phase
Phase 1/2
Study Type
Interventional
Last Updated