Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06662097

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California San Diego

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

About this study

This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be a minimum of 18 years of age
  • Study participant is planning to proceed with surgery
  • Willing to provide informed consent
  • Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
  • Females of childbearing potential must have a negative pregnancy test at screening and during the study.

Exclusion criteria

  • Patient has had prior surgery at the intended surgical site.
  • Patient has abnormal cardiac rhythm not controlled by medication.
  • Patient has moderate to severe renal impairment.
  • Patient has a history of fluorescein allergy.
  • Patient has a history of drug-related anaphylactic.
  • Presence of a concurrent disease or condition that may interfere with study participation.
  • Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
  • Use of any Investigational Product or investigational medial device within 30 days prior to screening.

Treatment and study plan

Bevonescein

Drug

Bevonescein is a sterile solution that is intravenously administered

Other names: ALM-488

Primary outcomes

  1. Fluorescence System Survey

    Time frame: 28 (+5 days)

    To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.

Secondary outcomes

  1. To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings

    Time frame: 28 (+5 days)

    The optimal dose for each of the identified surgical settings will be assessed by using three doses.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Stephens

CONTACT

[email protected]

6145569561

Sponsors and collaborators

Lead sponsor

Alume Biosciences, Inc.

Industry

Registry information

Official study title

Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.