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NCT02652923 · ClinicalTrials.gov registry record · Phase 1
Contrast Ultrasound Detection of Sentinel Lymph Nodes
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT02652923: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT02652923 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02652923, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation. Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the optimal dose as well as the safety and tolerability of the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to that of isotope mapping during surgery on 90 female, breast cancer patients.
Primary Outcome
To establish, in healthy, female volunteers, the optimal dose of subdermaly administrated Sonazoid (an ultrasound contrast agent) employed for contrast enhanced ultrasound imaging (CEUS)
Interventions
- DRUG Sonazoid; Perflubutane for Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2022-01-12 |
| Phase | Phase 1 |
What the finished NCT02652923 record still lists
NCT02652923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 1 intervention - of which Sonazoid; Perflubutane for Injection is the first listed.
NCT02652923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02652923 about?
NCT02652923 is a clinical study titled "Contrast Ultrasound Detection of Sentinel Lymph Nodes". This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation. Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the opt...
What is the current status of trial NCT02652923?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2016-01-01. Estimated completion is 2022-01-12.
What interventions are being tested in trial NCT02652923?
The interventions under investigation include: Sonazoid; Perflubutane for Injection (DRUG).
Who is sponsoring clinical trial NCT02652923?
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 NCT02652923's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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