Clinical trial · Interventional
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
NCT03578224CI-TRIAL-00089917completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA) | Procedure | — | UNRESOLVED |
| Fine-Needle Aspiration | Procedure | — | UNRESOLVED |
| Sonazoid (Perflubutane) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (EUS, FNA, perflubutane microbubble)
- description
- 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.
- interventionNames
- Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)
- Procedure: Contrast-Enhanced Ultrasound
- Procedure: Fine-Needle Aspiration
- Drug: Sonazoid (Perflubutane)
Primary outcomes (1)
- measure
- Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification
- timeFrame
- Up to 2 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.