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

Part of paid clinical trials in Duarte, California.

Sponsor
Vergent Bioscience, Inc.
Study ID
NCT07499674
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abenacianine — DRUG
    Intravenous drug to be given by syringe pump.
  • Near Infrared (NIR) Imaging — OTHER
    NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Abenacianine with surgery using Standard of Care (SOC) only
    Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only.
  • Other: Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging
    Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging.

Primary Outcome Measure

Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: [ Time Frame: Day of Surgery ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Jae Kim, MD
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Daryl Pearlstein, MD
University of Colorado HospitalAuroraColorado80045
Robert Meguid, MD
Orlando Health Cancer CenterOrlandoFlorida32806
Luis Herrera, MD
University of MichiganAnn ArborMichigan48109
Rishindra Reddy, MD
Mayo ClinicRochesterMinnesota55905
Janani Reisenauer, MD
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Sunil Singhal, MD
University of Texas, MD Anderson Cancer CenterHoustonTexas77030
David Rice, M.B., B.CH, B.A.O, F.R.C.S.I

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope National Medical Center· Duarte, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAUniversity of Colorado Hospital· Aurora, COOrlando Health Cancer Center· Orlando, FLUniversity of Michigan· Ann Arbor, MIMayo Clinic· Rochester, MN

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