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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9
Given subdermally
Undergo ultrasound
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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).
Time frame: up to 30 minutes during CEUS procedure
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Time frame: up to 30 minutes during CEUS procedure
Size of Sentinel Lymph Nodes (SLNs) Identified
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded.
Time frame: up to 30 minutes during CEUS procedure
Depth Beneath the Skin Surface of Each SLN
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded - \[this verbiage comes directly from the protocol\]
Time frame: up to 30 minutes during CEUS procedure
Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)
The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).
Time frame: Within 7 days post-surgery
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