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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Be willing and able to sign the informed consent and comply with study procedures. 2. Be at least 18 years of age. 3. Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent. 4. Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician. 5. Be able to meet the following conditions: 1. Female participants must be of non-childbearing potential, or, 2. If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment. 3. 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. 6. Have not participated in an interventional clinical trial within the last 30 days.

Exclusion Criteria

  1. They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine. 2. They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment. 3. 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. 4. They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Select Study Staff

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Abenacianine
    Intravenous drug to be given by syringe pump.
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.
  • 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.

Recruiting Locations

City of Hope National Medical Center
Duarte, California 91010
Contact:
Jae Kim, MD

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Robert Meguid, MD

Orlando Health Cancer Center
Orlando, Florida 32806
Contact:
Luis Herrera, MD

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Rishindra Reddy, MD

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Janani Reisenauer, MD

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Sunil Singhal, MD

University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
Contact:
David Rice, M.B., B.CH, B.A.O, F.R.C.S.I

More Details

Status
Recruiting
Sponsor
Vergent Bioscience, Inc.

Study Contact

Brian York
978-882-1403
byork@vergentbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.