NCT03578224

Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Esophagus

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)	Undergo EUS-FNA
PROCEDURE	Contrast-Enhanced Ultrasound	Undergo CEUS
PROCEDURE	Fine-Needle Aspiration	Undergo FNA
DRUG	Sonazoid (Perflubutane)	Sonazoid (ultrasound contrast agent) will be injected in 0.25 mL increments at 12, 3, 6, and 9 o'clock positions around the tumor using a 19 - 22 gauge needle system under EUS guidance

Timeline

• Start date: 2018-09-06
• Primary completion: 2022-08-25
• Completion: 2022-08-25
• First posted: 2018-07-06
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study