Gynecological Sentinel Lymph Nodes CEUS

NCT05105087 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: 21F.624R21CA249870JT 16886
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 30 minutes during CEUS procedure

Secondary Outcomes (4)

• 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

Study Arms (1)

Diagnostic (perflubutane microbubble, ultrasound)

EXPERIMENTAL

Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.

Drug: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound

Interventions

Perflubutane Microbubble DRUG

Given subdermally

Also known as: Sonazoid, gas-filled microbubbles

Diagnostic (perflubutane microbubble, ultrasound)

Contrast-Enhanced Ultrasound PROCEDURE

Undergo ultrasound

Also known as: CEUS

Diagnostic (perflubutane microbubble, ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Sonazoid

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases

Results Point of Contact

• Title: Ji-Bin Liu, MD
• Organization: Thomas Jefferson University

jxl120@jefferson.edu

215-955-4862

Study Officials

• Ji-Bin Liu, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: November 3, 2021
• Study Start: April 28, 2022
• Primary Completion: November 15, 2023
• Study Completion: January 29, 2025
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Locations

US (1)