Clinical trial NCT03578224: Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
Official title: Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Esophagus
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-06
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of nodes identified
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Ji-Bin Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: