Clinical trial NCT04420689: Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Official title: Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parotid Neoplasm
Thyroid Neoplasms
Head and Neck Neoplasms
Surgery
Nerve Injury
Imaging
Keywords: Nerve
Fluorescence
Surgery
Imaging
Real-time
Intraoperative
Highlighting
Lead sponsor: Alume Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.
Primary purpose: PREVENTION

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

Detailed description: This study will evaluate the safety, tolerability, and efficacy of Bevonescein (ALM-488) administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of Bevonescein (ALM-488) in this subject population and determine the dose of Bevonescein (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 Bevonescein (ALM-488) administration, relative to surgery, on fluorescence characteristics.

Eligibility 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.

Primary outcomes:
measure: Safety - The Number of Patients With ALM-488 Related Adverse Events
timeFrame: 28 (+5) days
Secondary outcomes:
Other outcomes:
measure: Time of Peak ALM-488 Concentration in Plasma (Cmax)
timeFrame: 28 (+5) days
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Harvard-Mass Eye & Ear
state: Massachusetts
Study officials:
References: