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

NCT07499674 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Abenacianine

Intravenous drug to be given by syringe pump.

OTHER

Near Infrared (NIR) Imaging

NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

Sponsors & Collaborators

  • Vergent Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Curtis Scribner, MD · Vergent Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499674 on ClinicalTrials.gov