Gynecological Sentinel Lymph Nodes CEUS

Thomas Jefferson University

Status and phase: Completed; Early Phase 1

Conditions: Malignant Female Reproductive System Neoplasm; Vulvar Carcinoma; Vaginal Carcinoma; Cervical Carcinoma

Treatments: Drug: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05105087

JT 16886 (Other Identifier)

R21CA249870 (U.S. NIH Grant/Contract)

21F.624

Details and patient eligibility

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: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Diagnostic (perflubutane microbubble, ultrasound)

Experimental group

Description:

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

Treatment:

Procedure: Contrast-Enhanced Ultrasound

Drug: Perflubutane Microbubble