Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
研究概览
简要总结
This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the concordance between lymphosonography and the standard of care in the identification sentinel lymph nodes (SLNs) in patients with cervical, vaginal or vulvar cancer.
II. To determine if lymphosonography can identify more SLNs with metastatic deposits in patients with cervical, vaginal or vulvar cancer when compared to the standard of care.
OUTLINE:
Patients receive perflubutane microbubble (Sonazoid) injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Be female
- •Be diagnosed with cervical, vaginal or vulvar cancer
- •Be at least 18 years of age
- •If of child-bearing potential, must have a negative pregnancy test
- •Be able to comply with study procedures
- •Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study
排除标准
- •Females who are pregnant or nursing
- •Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- •Patients on life support or in a critical care unit
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- •Patients with recent cerebral hemorrhage
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- •Patients with congenital heart defects
- •Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
研究组 & 干预措施
Diagnostic (perflubutane microbubble, ultrasound)
Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
干预措施: Perflubutane Microbubble (Drug)
Diagnostic (perflubutane microbubble, ultrasound)
Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
干预措施: Contrast-Enhanced Ultrasound (Procedure)
结局指标
主要结局
Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
时间窗: up to 30 minutes during CEUS procedure
The number of SLN detected by contrast enhanced ultrasound will be compared to the number of SLN detected by the standard of care (i.e., by blue dye or by PET-CT).
次要结局
- Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)(up to 30 minutes during CEUS procedure)
- Size of Sentinel Lymph Nodes (SLNs) Identified(up to 30 minutes during CEUS procedure)
- Depth Beneath the Skin Surface of Each SLN(up to 30 minutes during CEUS procedure)
- Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)(Within 7 days post-surgery)