Contrast-Enhanced Ultrasound Imaging Scan for the Detection of Sentinel Lymph Nodes in Patients With Cervical, Vaginal, or Vulvar Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. After completion of study intervention, patients are followed up for 30 days.

Official Title
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Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging

Conditions
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Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma

Intervention / Treatment
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* Drug: Perflubutane Microbubble
* Procedure: Contrast-Enhanced Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (perflubutane microbubble, ultrasound)<br>Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. | Drug: Perflubutane Microbubble<br>* Given subdermally<br>Procedure: Contrast-Enhanced Ultrasound<br>* Undergo ultrasound<br>* Other names: CEUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sentinel lymph nodes (SLNs) identified by lymphosonography as well as blue dye or positron emission tomography (PET)-computed tomography (CT) | 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) using paired t-test or paired Wilcoxon test (depending on whether the data is normal distributed or not). | At end of treatment; approximately 30 minutes |