Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/11/2018 |
| Start Date: | September 6, 2018 |
| End Date: | April 2021 |
| Contact: | Ji-Bin Liu, MD |
| Email: | Ji-Bin.Liu@jefferson.edu |
| Phone: | 215 955-4862 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Phone: 215-955-4862
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