NCT07499674

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
10mo left

Started Mar 2026

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 12, 2026

Last Update Submit

March 23, 2026

Conditions

Lung CancerLung Metastases

Keywords

Lung CancerMetastatic Cancer in Lung

Outcome Measures

Primary Outcomes (1)

  • Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by:

    A. Intraoperative localization of one or more preoperatively identified lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation fail to identify the lesion(s). B. Identification of one or more synchronous or occult lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation and preoperative imaging fail to identify the lesion(s).

    Day of Surgery

Secondary Outcomes (2)

  • Key Secondary Endpoints

    Day of surgery

  • Other Secondary Endpoints

    Day of surgery

Other Outcomes (2)

  • Pharmacokinetic Endpoint

    Pre-dose through 24 hrs post-dose

  • Pharmacokinetic Endpoint

    Pre-dose through 24 hrs post-dase

Study Arms (2)

Abenacianine with surgery using Standard of Care (SOC) only

OTHER

Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only.

Drug: Abenacianine

Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging

OTHER

Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging.

Drug: AbenacianineOther: Near Infrared (NIR) Imaging

Interventions

AbenacianineDRUG

Intravenous drug to be given by syringe pump.

Abenacianine with surgery using Standard of Care (SOC) onlyAbenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging
Near Infrared (NIR) ImagingOTHER

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

Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Be able to meet the following conditions:
  • Female participants must be of non-childbearing potential, or,
  • If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.
  • Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days after dosing.
  • Have not participated in an interventional clinical trial within the last 30 days.

You may not qualify if:

  • They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
  • They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment.
  • They have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study. They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
  • They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope National Medical Center

Duarte, California, 91010, United States

NOT YET RECRUITING

Orlando Health Cancer Center

Orlando, Florida, 32806, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Curtis Scribner, MD

    Vergent Bio

    STUDY DIRECTOR

Central Study Contacts

Brian York

CONTACT

978-882-1403byork@vergentbio.com

Eric Bensen, PhD

CONTACT

952-479-7496ebensen@vergentbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Select Study Staff
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized and intrasubject controlled study in which all participants will receive a dose of 0.31mg/kg of abenaniacine 12-96 hours before surgery.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.

Locations

US(5)AU(1)