Clinical trial NCT05105087: Gynecological Sentinel Lymph Nodes CEUS
Official title: Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cervical Carcinoma
Malignant Female Reproductive System Neoplasm
Vaginal Carcinoma
Vulvar Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-03
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Number of sentinel lymph nodes (SLNs) identified by lymphosonography as well as blue dye or positron emission tomography (PET)-computed tomography (CT)
timeFrame: 30 minutes
Secondary outcomes:
measure: The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded
timeFrame: 30 minutes
measure: Presence or absence of metastatic deposits in the Sentinel Lymph Node (SLNs)
timeFrame: 7 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: