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临床试验/NCT04248153
NCT04248153终止2 期

An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women

Bracco Diagnostics, Inc1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年10月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
3
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Enroll a subject in this study if the subject meets the following inclusion criteria:
  • Is a female subject of at least 18 years of age;
  • Is premenopausal;
  • Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second BR55 CEUS examination;
  • 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 administration,
  • by surgical history (e.g., tubal ligation or hysterectomy),
  • 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 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

Group A

Experimental

BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.

干预措施: BR55 (Drug)

Group B

Experimental

BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.

干预措施: BR55 (Drug)

结局指标

主要结局

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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