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Tests treatment safety and results for Lung Cancer
Official title Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
ClinicalTrials.gov ID: NCT07499674
What this study is testing
What is Abenacianine?
Abenacianine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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:
You likely can't join 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 prisoners, institutionalized individuals, or are unable to consent for themselves.
See the full eligibility criteria
- 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...
- Have not participated in an treatment clinical trial within the last 30 days.
- 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...
- They are prisoners, institutionalized individuals, or are unable to consent for themselves.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Newport Beach, California, United States
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Fitzroy, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Newport Beach, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.