Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung

This is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants receiving abenacianine and undergoing NIR imaging and a control group of 12 participants who will receive abenacianine but no NIR imaging.

Trial Details

NCT ID
NCT07499674
Phase
PHASE3
Sponsor
Vergent Bioscience, Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Abenacianine
  • Near Infrared (NIR) Imaging
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Newport Beach, California, United States|33.61891,-117.92895
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Orlando, Florida, United States|28.53834,-81.37924
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility Criteria

  • Be willing and able to sign the informed consent and comply with study procedures.
  • Be at least 18 years of age.
  • Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.
  • Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician.

For full eligibility, visit ClinicalTrials.gov.

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