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NCT05105087 · REGISTRY CONDITION SEARCH

Gynecological Sentinel Lymph Nodes CEUS

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
EARLY PHASE1
Status at capture
COMPLETED
Registry last update
2025-08-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)

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outcome · POSTED

Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)

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outcome · POSTED

Size of Sentinel Lymph Nodes (SLNs) Identified

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outcome · POSTED

Depth Beneath the Skin Surface of Each SLN

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outcome · POSTED

Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
    intervention Names
    1. Drug: Perflubutane Microbubble
    2. Procedure: Contrast-Enhanced Ultrasound
    label
    Diagnostic (perflubutane microbubble, ultrasound)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Diagnostic (perflubutane microbubble, ultrasound)
    description
    Given subdermally
    name
    Perflubutane Microbubble
    other Names
    1. Sonazoid
    2. gas-filled microbubbles
    type
    DRUG
  2. arm Group Labels
    1. Diagnostic (perflubutane microbubble, ultrasound)
    description
    Undergo ultrasound
    name
    Contrast-Enhanced Ultrasound
    other Names
    1. CEUS
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
DIAGNOSTIC
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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).
    measure
    Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
    time Frame
    up to 30 minutes during CEUS procedure
secondary Outcomes
  1. measure
    Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
    time Frame
    up to 30 minutes during CEUS procedure
  2. description
    The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded.
    measure
    Size of Sentinel Lymph Nodes (SLNs) Identified
    time Frame
    up to 30 minutes during CEUS procedure
  3. description
    The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded - \[this verbiage comes directly from the protocol\]
    measure
    Depth Beneath the Skin Surface of Each SLN
    time Frame
    up to 30 minutes during CEUS procedure
  4. description
    The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).
    measure
    Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)
    time Frame
    Within 7 days post-surgery
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      query cond
      Vulvar Cancer
      query disease state id
      ds-vulvar-cancer
      source file
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      payload sha256
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      payload
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      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
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      source file sha256
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    Preserved source evidence · Not medical advice