Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 1. Visual Assessment of Enhancement
研究概览
简要总结
This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 contrast-enhanced ultrasonography (CEUS) for characterization of solid pancreatic lesions in subjects with suspected pancreatic ductal adenocarcinoma (PDAC) using transabdominal US.
详细描述
Approximately twenty-four (24) subjects with suspected PDAC and scheduled to undergo surgical resection within 30 days (but not before 24 hours) after the transabdominal BR55 CEUS examination will be enrolled into 3 dose groups, 0.03, 0.05, and 0.08 mL/kg, with a maximum of 8 patients in each dose group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Enroll a subject in this study if the subject meets the following inclusion criteria:
- •Is at least 18 years of age;
- •Has at least one solid pancreatic lesion;
- •Is scheduled to undergo surgical resection for suspected PDAC not earlier than 24 hours and not later than 30 days following BR55 administration;
- •Provides written Informed Consent and is willing to comply with protocol requirements.
排除标准
- •Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy:
- •by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product (IP) administration,
- •by surgical history (e.g., tubal ligation or hysterectomy),
- •by post-menopausal status with a minimum 1 year without menses;
- •Has undergone prior systemic therapy for pancreatic cancer;
- •Has history of any concurrent malignancy;
- •Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
- •Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
- •Has severe pulmonary hypertension (pulmonary artery pressure > 90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome;
- •Has open and/or non-healing wounds in the chest, abdomen and pelvis;
- •Has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
- •Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment;
- •Has previously been enrolled in and completed this study;
- •Has any known allergy to one or more of the ingredients of the IP or to any other contrast media;
- •Is determined by the Investigator that the subject is clinically unsuitable for the study;
- •Has had major surgery, including laparoscopic surgery within 3 months prior to enrolment;
- •Has history of pancreatic surgery (e.g., cyst removal);
- •Has acute pancreatic abnormalities (acute pancreatitis or trauma).
研究组 & 干预措施
0.03mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
干预措施: BR55 (Drug)
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
干预措施: BR55 (Drug)
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
干预措施: BR55 (Drug)
结局指标
主要结局
1. Visual Assessment of Enhancement
时间窗: Up to 24 hours post-dose on Day 1
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
2. Adverse Events
时间窗: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Number of participants who received the contrast agent and experienced an adverse event.
次要结局
未报告次要终点