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About
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.
Full 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.
Enrollment
Sex
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Inclusion criteria
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 with congenital heart defects
Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Central trial contact
Ji-Bin Liu, MD
Data sourced from clinicaltrials.gov
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