Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

NCT ID: NCT06227585

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2025-12-31

Brief Summary

A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.

Detailed Description

The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy or neck dissection surgery.

Conditions

Head and Neck Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm (Bevonescein)

All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients.

Group Type: EXPERIMENTAL

REVEAL 475 System

Intervention Type: DEVICE

The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.

Bevonescein

Intervention Type: DRUG

All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.

Interventions

REVEAL 475 System

The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.

Intervention Type: DEVICE

Bevonescein

All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.

Intervention Type: DRUG

Other Intervention Names

ALM-488

Eligibility Criteria

Inclusion Criteria

• Minimum of 16 years of age.
• Planning to undergo surgery in the Head and Neck.
• Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.
• Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
• Sexually active patients must be willing to use an acceptable method of contraception while participating in the study and for 30 days after receiving bevonescein.
• Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.

Exclusion Criteria

• Patient has a history of prior surgery and/or radiation to the intended surgical site.
• Patient has abnormal cardiac rhythm not controlled with medication.
• Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min.
• Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.
• Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy <= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.
• Patient has a history of fluorescein allergy.
• Patient has a history of drug-related anaphylactic or severe allergic reactions.
• Presense or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the Investigator, places the patient at increased risk for adverse effects.
• Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction, or cerebrovascular accident.
• Presence or history of any condition, that in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
• Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study.
• Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alume Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Berman, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

Jacobs Medical Center at UC San Diego Health

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brett Berman, MD

Role: CONTACT

brett.berman@alumebiosciences.com

858-922-3977

Kim Potter

Role: CONTACT

kim.potter@alumebiosciences.com

706-338-1158

Facility Contacts

Michael Bouvet, MD

Role: primary

mbouvet@health.ucsd.edu

858-246-2223

Other Identifiers

ALM-488-003

Identifier Type: -

Identifier Source: org_study_id