Gynecological Sentinel Lymph Nodes CEUS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Carcinoma; Vaginal Carcinoma; Malignant Female Reproductive System Neoplasm; Vulvar Carcinoma
• Intervention / Treatment: Drug: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ji-Bin Liu, MD; Phone Number: 215-955-4862; Email: ji-bin.liu@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Ji-Bin Liu, MD; Phone Number: 215-955-4862; Email: jxl120@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (perflubutane microbubble, ultrasound); Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.	Drug: Perflubutane Microbubble; Given subdermally; Procedure: Contrast-Enhanced Ultrasound; Undergo ultrasound; Other Names: CEUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) using paired t-test or paired Wilcoxon test (depending on whether the data is normal distributed or not).	30 minutes. Analysis of imaging modalities and pathology is number of sentinel lymph nodes identified therefore there not an issue with units of measurement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each Sentinel Lymph Nodes (SLN)	Will be recorded.	The time frame is the duration of an ultrasound study which is 30 minutes where the sentinel lymph node will be identified and measured.
Presence or absence of metastatic deposits in the Sentinel Lymph Node (SLNs)	The percentage of SLNs with metastatic deposits identified by lymphosonography and by blue dye will be pairwise compared after eliminating the SLNs identified by both methods using two-sample t-test or Wilcoxon test (again after testing for normalcy). The histopathological assessment of the surgically removed lymph nodes will serve as the reference standard.	Time frame for lymphosonography is 30 minutes. Blue dye information available in pathology report in 7 days

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Vaginal Diseases; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma; Vulvar Neoplasms; Genital Neoplasms, Female; Vaginal Neoplasms
• Other Study ID Numbers: 21F.624; R21CA249870 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No