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

Primary Purpose

Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Perflubutane Microbubble
Contrast-Enhanced Ultrasound
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (perflubutane microbubble, ultrasound)

Arm Description

Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 13, 2021
Last Updated
June 2, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05105087
Brief Title
Contrast-Enhanced Ultrasound Imaging Scan for the Detection of Sentinel Lymph Nodes in Patients With Cervical, Vaginal, or Vulvar Cancer
Official Title
Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
June 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (perflubutane microbubble, ultrasound)
Arm Type
Experimental
Arm Description
Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
Intervention Type
Drug
Intervention Name(s)
Perflubutane Microbubble
Intervention Description
Given subdermally
Intervention Type
Procedure
Intervention Name(s)
Contrast-Enhanced Ultrasound
Other Intervention Name(s)
CEUS
Intervention Description
Undergo ultrasound
Primary Outcome Measure Information:
Title
Number of sentinel lymph nodes (SLNs) identified by lymphosonography as well as blue dye or positron emission tomography (PET)-computed tomography (CT)
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) using paired t-test or paired Wilcoxon test (depending on whether the data is normal distributed or not).
Time Frame
At end of treatment; approximately 30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Bin Liu, MD
Phone
215-955-4862
Email
jxl120@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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

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