Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-06

Study Completion Date

2022-08-25

Brief Summary

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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.

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Detailed Description

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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

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Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (EUS, FNA, perflubutane microbubble)

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Undergo EUS-FNA

Contrast-Enhanced Ultrasound

Intervention Type PROCEDURE

Undergo CEUS

Fine-Needle Aspiration

Intervention Type PROCEDURE

Undergo FNA

Sonazoid (Perflubutane)

Intervention Type 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

Interventions

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

Undergo EUS-FNA

Intervention Type PROCEDURE

Contrast-Enhanced Ultrasound

Undergo CEUS

Intervention Type PROCEDURE

Fine-Needle Aspiration

Undergo FNA

Intervention Type PROCEDURE

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No