Contrast-Enhanced Ultrasound Imaging Scan for the Detection of Sentinel Lymph Nodes in Patients With Cervical, Vaginal, or Vulvar Cancer

  • STATUS
    Recruiting
  • End date
    Jun 21, 2024
  • participants needed
    40
  • sponsor
    Thomas Jefferson University
Updated on 4 October 2022
cancer
cancer treatment
primary cancer
diagnostic procedures
lab tests

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.

Details
Condition Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
Treatment Contrast-enhanced ultrasound, Perflubutane Microbubble
Clinical Study IdentifierNCT05105087
SponsorThomas Jefferson University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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