BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Visual Assessment of BR55 Enhancement
研究概览
简要总结
This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.
详细描述
A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the TS.
The first 10 subjects will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.
The final cancer diagnosis will be obtained for all subjects by histopathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Enroll a subject if he/she meets the following inclusion criteria:
- •Is at least 18 years of age;
- •Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;
- •Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer 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 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 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 ovarian cancer;
- •Has history of 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 Investigational Product 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 surgery to the ovaries or pelvic inflammatory disease.
研究组 & 干预措施
Treatment
Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.
干预措施: BR55 (Drug)
结局指标
主要结局
Visual Assessment of BR55 Enhancement
时间窗: 30 minutes post-dose on Day 1
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).
Adverse Events
时间窗: 2 days (day of and 24 hours after BR55 administration)
Number of participants who received the contrast agent and experienced an adverse event.
次要结局
未报告次要终点