Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

NCT03578224 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Esophagus

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Ji-Bin Liu, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2022-08-25
Completion
2022-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578224 on ClinicalTrials.gov