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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 10
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Select Study Staff
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 days after dosing.
- •Have not participated in an interventional clinical trial within the last 30 days.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Near Infrared (NIR) Imaging (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.
干预措施: Abenacianine (Drug)
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.
干预措施: Abenacianine (Drug)