Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: National Cancer Institute (NCI)

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.