Clinical trial NCT06227585: Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery
Official title: Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Surgery
Keywords: parotidectomy
thyroidectomy
neck dissection
ALM-488
bevonescein
nerve
fluorescence
head and neck surgery
intra-operative
real-time
REVEAL 475
Lead sponsor: Alume Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgeon perspective on REVEAL 475 system blue light illumination
timeFrame: Immediately after surgery
measure: Surgeon perspective on REVEAL 475 system ease of use
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Plasma concentration of bevonescein
timeFrame: 1.5-5 hours before surgery, during surgery, and 0-12 hours after surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Jacobs Medical Center at UC San Diego Health
state: California
Study officials:
affiliation: Chief Medical Officer
name: Brett Berman, MD
role: STUDY_DIRECTOR
References: