Gynecological Sentinel Lymph Nodes CEUS

NCT05105087 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Cervical Carcinoma
  • Malignant Female Reproductive System Neoplasm
  • Vaginal Carcinoma
  • Vulvar Carcinoma

Interventions

DRUG

Perflubutane Microbubble

Given subdermally

PROCEDURE

Contrast-Enhanced Ultrasound

Undergo ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Ji-Bin Liu, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-11-15
Completion
2025-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105087 on ClinicalTrials.gov