Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

NCT03578224 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: 18F.235R21CA218946JT 12449
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification

  The number and locations of the nodes identified by the two imaging approaches (contrast-enhanced ultrasound \[CEUS\] and unenhanced EUS) will be compared using McNemar's test for correlated proportions as well as using a one-sided t-test with a Wilcoxon non-parametric adjustment (normal distribution will be tested) with pathology as the reference standard for sentinel lymph node detection and considering exact binomial p-values less than 0.05 to be significant. The findings of lymphosonography will be correlated to pathological findings (including degree of metastatic involvement) to determine sensitivity and specificity and the rate of cancerous nodes identified by CEUS relative to those of unenhanced EUS using a clustered conditional logistic regression analysis of correlated proportions (equivalent to a clustered McNemar's test).

  Up to 2 years

Secondary Outcomes (1)

• Number of nodes identified

  Up to 2 years

Study Arms (1)

Diagnostic (EUS, FNA, perflubutane microbubble)

EXPERIMENTAL

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.

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

Interventions

Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA) PROCEDURE

Undergo EUS-FNA

Diagnostic (EUS, FNA, perflubutane microbubble)

Contrast-Enhanced Ultrasound PROCEDURE

Undergo CEUS

Diagnostic (EUS, FNA, perflubutane microbubble)

Fine-Needle Aspiration PROCEDURE

Undergo FNA

Diagnostic (EUS, FNA, perflubutane microbubble)

Sonazoid (Perflubutane) DRUG

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

Diagnostic (EUS, FNA, perflubutane microbubble)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Biopsy, Fine-Needle; Sonazoid; perfluorobutane

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Punctures

Study Officials

• Ji-Bin Liu, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: September 6, 2018
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)