Gynecological Sentinel Lymph Nodes CEUS

Cervical Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105087
• Other study ID #: 21F.624
• Secondary ID: R21CA249870
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 28, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Ji-Bin Liu, MD
• Phone: 215-955-4862
• Email: ji-bin.liu[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Vaginal Carcinoma
• Vaginal Neoplasms
• Vulvar Carcinoma
• Vulvar Neoplasms

Intervention

Drug:
• Perflubutane Microbubble
Given subdermally

Procedure:
• Contrast-Enhanced Ultrasound
Undergo ultrasound

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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