Gynecological Sentinel Lymph Nodes CEUS

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05105087

Enrollment

Registered

2021-11-03

Start date

2022-04-28

Completion date

2025-01-29

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGPerflubutane Microbubble

Given subdermally

PROCEDUREContrast-Enhanced Ultrasound

Undergo ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)	up to 30 minutes during CEUS procedure	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).

Secondary

Measure	Time frame	Description
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	The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded.
Depth Beneath the Skin Surface of Each SLN	up to 30 minutes during CEUS procedure	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 of Metastatic Deposits in the Sentinel Lymph Node (SLNs)	Within 7 days post-surgery	The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).

Countries

United States

Participant flow

Recruitment details

This was a single-site, open-label, non-randomized pilot study conducted at Thomas Jefferson University (TJU), Sidney Kimmel Cancer Center, Philadelphia, PA. Subject recruitment was expected to last 24 months, beginning in April 2022 and ending in November 2023. Recruitment was conducted from the patient population of the Department of Gynecology Oncology at TJU. Eligible participants were identified by surgical co-investigators from their existing patient population.

Pre-assignment details

Screening assessments were performed within 4 weeks prior to the administration of Sonazoid. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history were recorded. 9 participants received CEUS. 5 completed both CEUS and surgery with pathology and were analyzed. 2 were ineligible for surgery (advanced disease), and 2 withdrew consent prior to surgery; thus no outcome data were available for these 4 participants.

Participants by arm

Arm	Count
Diagnostic (Perflubutane Microbubble, Ultrasound) Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound	5
Total	5

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Ineligible for surgery due to advanced disease	2
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Diagnostic (Perflubutane Microbubble, Ultrasound)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	1 Participants
Age, Categorical Between 18 and 65 years	4 Participants
Age, Continuous	55 years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	1 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 9
other Total, other adverse events	0 / 9
serious Total, serious adverse events	0 / 9

Outcome results

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).

Time frame: up to 30 minutes during CEUS procedure