RightFit
RecruitingPhase 3

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, 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe abenacianine is and how well it helps doctors find cancer during lung surgery. It is an injected drug that makes tumors light up with special imaging. The study is for adults planning surgery to remove a lung lump or mass.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Be willing and able to sign a form agreeing to join and follow study steps.
  • Plan to have a lung lump or mass removed to check for cancer or try to cure it.
  • Meet all requirements for surgery, as judged by your doctors.
  • Women must be unable to become pregnant, or meet the study’s pregnancy, breastfeeding, and birth control rules. Highly effective birth control is required if able to become pregnant, from screening until 30 days after treatment.
  • Men who have not had surgery to prevent pregnancy must use highly effective birth control if having sex with a woman who can become pregnant, from screening until 30 days after dosing.
  • Have not taken part in a trial testing a treatment or procedure in the past 30 days.

Who can't join

  • Have a known allergy or reaction to imaging contrast dyes, ICG (an imaging dye), or any part of abenacianine.
  • Have received chemotherapy, immune-based cancer treatment, or radiation treatment within 4 weeks before joining.
  • Have another health condition or habit that the study doctor believes would keep you from following or finishing the study.
  • Be unable to have standard surgery, as judged by your doctors.
  • Be a prisoner, live in an institution, or be unable to give your own consent to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (8)

CA

CO

  • University of Colorado Hospital · Aurora, CO 80045Robert Meguid, MD · Study contactMore trials in Aurora

FL

MI

MN

PA

TX

  • University of Texas, MD Anderson Cancer Center · Houston, TX 77030David Rice, M.B., B.CH, B.A.O, F.R.C.S.I · Study contactMore trials in Houston