RECRUITING

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

Conditions

Head and Neck Surgery parotidectomy thyroidectomy neck dissection ALM-488 bevonescein nerve fluorescence intra-operative real-time REVEAL 475

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery

Quick Facts

Study Start:2023-11-29

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06227585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Brett Berman, MD

CONTACT

858-922-3977

brett.berman@alumebiosciences.com

Kim Potter

CONTACT

706-338-1158

kim.potter@alumebiosciences.com

Principal Investigator

Brett Berman, MD

STUDY_DIRECTOR

Chief Medical Officer

Study Locations (Sites)

Jacobs Medical Center at UC San Diego Health

San Diego, California, 92093

United States

Collaborators and Investigators

Sponsor: Alume Biosciences, Inc.

Brett Berman, MD, STUDY_DIRECTOR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-11-29

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

parotidectomy
thyroidectomy
neck dissection
ALM-488
bevonescein
nerve
fluorescence
head and neck surgery
intra-operative
real-time
REVEAL 475

Additional Relevant MeSH Terms

Head and Neck Surgery