Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Early Phase 1

Conditions: Esophagus

Treatments: Procedure: Fine-Needle Aspiration; Procedure: Contrast-Enhanced Ultrasound; Drug: Sonazoid (Perflubutane); Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03578224

R21CA218946 (U.S. NIH Grant/Contract)

JT 12449 (Other Identifier)

18F.235

Details and patient eligibility

About

This pilot trial studies how well an ultrasound with a contrast agent (perflubutane microbubble [Sonazoid]) works in identifying sentinel lymph nodes in participants with esophageal cancer. Sentinel lymph nodes are lymph nodes to which the cancer is likely to spread from the primary tumor. Diagnostic procedures, such as contrast-enhanced ultrasound, may work better in identifying sentinel lymph nodes and finding out how far the disease has spread.

Full description

PRIMARY OBJECTIVES:

I. To assess the accuracy of contrast-enhanced endoscopic lymphosonography guided fine-needle aspiration (FNA) of sentinel lymph nodes compared with unenhanced endoscopic ultrasonography (EUS) guided FNA in the characterization of esophageal cancer-associated lymph nodes using pathology as the reference standard.

SECONDARY OBJECTIVES:

I. To assess the ability of contrast-enhanced endoscopic lymphosonography guided FNA compared with unenhanced EUS guided FNA in the overall detection of biopsy proven cancer-involved sentinel lymph nodes.

II. To assess the impact of overall tumor staging by contrast-enhanced endoscopic lymphosonography compared with unenhanced EUS.

Enrollment: 35 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with esophageal cancer.
• Be scheduled for staging endoscopic ultrasound with the intent for lymph node evaluation.
• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Be medically stable.
• If a female and pre-menopausal, must have a negative pregnancy test.

Exclusion criteria

• Females who are pregnant or nursing.
• Patients with other primary cancers requiring systemic treatment.
• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable.
• Patients with known hypersensitivity or allergy to any component of Sonazoid.
• Patients with cardiac shunts or unstable cardiopulmonary conditions.
• Patients with congenital heart defects.
• Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension, respiratory distress syndrome, or a history of pulmonary embolism.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Diagnostic (EUS, FNA, perflubutane microbubble)

Experimental group

Description:

Participants undergo standard of care unenhanced endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of identified lymph nodes. Participants then receive perflubutane microbubble peri- or intratumorally and undergo contrast-enhanced EUS followed by FNA of identified lymph nodes.

Treatment:

Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)

Drug: Sonazoid (Perflubutane)

Procedure: Contrast-Enhanced Ultrasound

Procedure: Fine-Needle Aspiration