Contrast-Enhanced Ultrasound Imaging Scan for the Detection of Sentinel Lymph Nodes in Patients With Cervical, Vaginal, or Vulvar Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (perflubutane microbubble, ultrasound) Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. |
Drug: Perflubutane Microbubble
Given subdermally
Procedure: Contrast-Enhanced Ultrasound
Undergo ultrasound
Other Names:
|
Outcome Measures
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) [At end of treatment; approximately 30 minutes]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be female
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Be diagnosed with cervical, vaginal or vulvar cancer
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Be at least 18 years of age
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If of child-bearing potential, must have a negative pregnancy test
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Be able to comply with study procedures
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Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study
Exclusion Criteria:
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Females who are pregnant or nursing
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Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
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Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
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Patients on life support or in a critical care unit
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Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
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Patients with recent cerebral hemorrhage
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Patients who have undergone surgery within 24 hours prior to the study sonographic examination
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Patients with congenital heart defects
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Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Thomas Jefferson University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21F.624