Gynecological Sentinel Lymph Nodes CEUS

Early Phase 1

Completed

• Conditions: Malignant Female Reproductive System Neoplasm; Vaginal Carcinoma; Vulvar Carcinoma; Cervical Carcinoma
• Interventions: Drug: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound

• Registration Number: NCT05105087
• Lead Sponsor: Thomas Jefferson University

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.

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.

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-03
• Study Start: 2022-04-28
• Primary Completion: 2023-11-15
• Study Completion: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (perflubutane microbubble, ultrasound)	Perflubutane Microbubble	Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
Diagnostic (perflubutane microbubble, ultrasound)	Contrast-Enhanced Ultrasound	Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.

Primary Outcome Measures

Name	Time	Method
Number of sentinel lymph nodes (SLNs) identified by lymphosonography as well as blue dye or positron emission tomography (PET)-computed tomography (CT)	30 minutes	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).

Secondary Outcome Measures

Name	Time	Method
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded	30 minutes	The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded - \[this verbiage comes directly from the protocol\]
Presence or absence of metastatic deposits in the Sentinel Lymph Node (SLNs)	7 days	The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States