Search / Trial NCT06227585

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

Launched by ALUME BIOSCIENCES, INC. · Jan 18, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Parotidectomy Thyroidectomy Neck Dissection Alm 488 Bevonescein Nerve Fluorescence Head And Neck Surgery Intra Operative Real Time Reveal 475

ClinConnect Summary

This clinical trial is looking at a new tool called the REVEAL 475 system to help doctors see nerves more clearly during head and neck surgeries. The study is specifically testing how well this system works with a special dye called bevonescein, which helps highlight the nerves during surgery. This research is currently recruiting participants who are 16 years old or older and are scheduled to have surgeries like parotidectomy (removal of the parotid gland), thyroidectomy (removal of the thyroid), or cervical neck dissection.

To join the study, participants must be able to provide consent and may need to follow certain guidelines, such as using contraception if they are sexually active. However, not everyone can participate; those with certain health conditions, such as severe heart problems or allergies to the dye, may be excluded. If chosen, participants can expect to receive the bevonescein dye before their surgery, and the study aims to ensure their safety and comfort throughout the process. This trial is an important step in improving surgical techniques and outcomes for patients undergoing head and neck surgery.

Gender

ALL

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.

Trial Officials

Brett Berman, MD

Study Director

Chief Medical Officer

About Alume Biosciences, Inc.

Alume Biosciences, Inc. is a pioneering biopharmaceutical company dedicated to advancing the field of precision medicine through the development of innovative therapies for unmet medical needs. With a strong focus on harnessing cutting-edge technologies and a commitment to rigorous scientific research, Alume aims to deliver transformative solutions that improve patient outcomes. The company's collaborative approach fosters partnerships with leading academic institutions and healthcare organizations, positioning Alume at the forefront of drug discovery and development in the biosciences sector. Through its dedication to excellence and patient-centric solutions, Alume Biosciences strives to make a meaningful impact on the lives of individuals facing complex health challenges.

Locations

Philadelphia, Pennsylvania, United States

Detroit, Michigan, United States

Albuquerque, New Mexico, United States

Philadelphia, Pennsylvania, United States

Boston, Massachusetts, United States

San Diego, California, United States

Charleston, South Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0