Abenacianine + NIR Imaging for Lung Cancer

(VISUALIZE-2 Trial)

Recruiting at 5 trial locations

Overseen By Eric Bensen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vergent Bioscience, Inc.

Must not be taking: Chemotherapy, Immunotherapy, Radiotherapy

Disqualifiers: Allergy to contrast agents, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Curtis Scribner, MD

Principal Investigator

Vergent Bio

Are You a Good Fit for This Trial?

Inclusion Criteria

I am at least 18 years old.

I am planning to have surgery to remove a lung lesion or mass.

I use effective birth control if I am a male who could father a child.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Participants receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery

1 week

1 visit (in-person)

Surgery and Imaging

Participants undergo surgery with or without NIR imaging to identify cancerous lesions

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abenacianine

How Is the Trial Designed?

Group I: Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging Experimental Treatment 2 Interventions

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

Group II: Abenacianine with surgery using Standard of Care (SOC) only Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Vergent Bioscience, Inc.

Lead Sponsor

Trials

2

Recruited

140+