Clinical Trials Directory

Trials / Completed

CompletedNCT05105087

Gynecological Sentinel Lymph Nodes CEUS

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

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Thomas Jefferson University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGPerflubutane MicrobubbleGiven subdermally
PROCEDUREContrast-Enhanced UltrasoundUndergo ultrasound

Timeline

Start date
2022-04-28
Primary completion
2023-11-15
Completion
2025-01-29
First posted
2021-11-03
Last updated
2025-08-22
Results posted
2025-08-22

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05105087. Inclusion in this directory is not an endorsement.