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NCT03578224 · ClinicalTrials.gov registry record · Early Phase 1
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
NCT03578224: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03578224 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 35 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03578224, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Contrast-Enhanced Ultrasound
- PROCEDURE Fine-Needle Aspiration
- PROCEDURE Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)
- DRUG Sonazoid (Perflubutane)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2022-08-25 |
| Phase | Early Phase 1 |
What the finished NCT03578224 record still lists
NCT03578224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Contrast-Enhanced Ultrasound is the first listed.
NCT03578224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03578224 about?
NCT03578224 is a clinical study titled "Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer". 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. Diagnos...
What is the current status of trial NCT03578224?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2018-09-06. Estimated completion is 2022-08-25.
What interventions are being tested in trial NCT03578224?
The interventions under investigation include: Contrast-Enhanced Ultrasound (PROCEDURE), Fine-Needle Aspiration (PROCEDURE), Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA) (PROCEDURE), Sonazoid (Perflubutane) (DRUG).
Who is sponsoring clinical trial NCT03578224?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03578224's enrollment target sits among peer trials
35 735th of 2000 higher than 1,254 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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