Lung CancerPhase 3VISUALIZE-2NCT07499674
Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
A Phase 3 study testing Abenacianine and Near Infrared (NIR) Imaging in people with Lung Cancer and Lung Metastases, run by Vergent Bioscience, Inc. at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Metastases
- What is being tested?
- Abenacianine and Near Infrared (NIR) Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 31 Mar 2026to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Rishindra Reddy, MD
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Robert Meguid, MD
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Jae Kim, MD
- Recruiting
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
David Rice, M.B., B.CH, B.A.O, F.R.C.S.I
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Daryl Pearlstein, MD
- Recruiting
Orlando Health Cancer Center
Orlando, Florida, 32806
Luis Herrera, MD
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sunil Singhal, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Janani Reisenauer, MD
Australia1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Gavin Wright, MD, Cardiothoracic.Research@svha.org.au
About this study
Official title: A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2
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
- Lung Cancer, Lung Metastases
- Being tested
- Abenacianine, Near Infrared (NIR) Imaging
- Keywords
- Lung Cancer, Metastatic Cancer in Lung
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbenacianineDrug
Intravenous drug to be given by syringe pump.
Near Infrared (NIR) ImagingOther
NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Abenacianine; Other: Near Infrared (NIR) Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by:
- 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).
- 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).
Measured: Day of Surgery
Secondary outcomes (4)
Key Secondary Endpoints
To evaluate the Population False Positive Rate for lesions (PFPR-L). A false-positive lesion is defined as tissue that fluoresces and is determined by histopathology to be normal (non-pathological).
Measured: Upon receipt of histopathology report (~2-3 weeks post surgery)
Key Secondary
To evaluate the Population False Positive Rate for lymph nodes (PFPR-LN). A false-positive lymph node is defined as a resected lymph node that fluoresces and is determined by histopathology to be non-cancerous.
Measured: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Key Secondary
To evaluate the proportion of participants who have at least one lymph node resected due to fluorescence that would not have been removed under the protocol defined standard of care (SOC) and is confirmed by histopathologic examination to be cancerous.
Measured: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Other Secondary Endpoints
To evaluate the sensitivity and specificity of abenacianine.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start31 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vergent Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curtis Scribner, MD, Study director, Vergent Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499674
- Sponsor's protocol ID
- VGT-309-3-2025
- Acronym
- VISUALIZE-2
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2
- ClinicalTrials.gov ID
- NCT07499674
- Acronym / sponsor ID
- VISUALIZE-2 / VGT-309-3-2025
- Conditions
- Lung Cancer, Lung Metastases
- Keywords
- Lung Cancer, Metastatic Cancer in Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Vergent Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Abenacianine with surgery using Standard of Care (SOC) only | Other | Drug: AbenacianineParticipants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only. |
| Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging | Other | Drug: Abenacianine, Other: Near Infrared (NIR) ImagingParticipants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbenacianineIntravenous drug to be given by syringe pump. | Drug | Abenacianine with surgery using Standard of Care (SOC) only, Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging |
| Near Infrared (NIR) ImagingNIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging. | Other | Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging |
Primary outcome
Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by:
Time frame: Day of Surgery
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).
4 secondary outcomes
Key Secondary Endpoints
Time frame: Upon receipt of histopathology report (~2-3 weeks post surgery)
Key Secondary
Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Key Secondary
Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Other Secondary Endpoints
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Curtis Scribner, MD study director
Vergent Bio
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abenacianine and Near Infrared (NIR) Imaging in people with Lung Cancer and Lung Metastases, run by Vergent Bioscience, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian York (978-882-1403, byork@vergentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: (time frame: Day of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.