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NCT00829413 · ClinicalTrials.gov registry record · Phase 3
SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
A Phase 3 study, sponsored by Bracco Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
NCT00829413: Completed Phase 3 study, sponsored by Bracco Diagnostics.
NCT00829413 is a Phase 3 study that has completed, run by Bracco Diagnostics. The registered enrollment target is 353 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00829413, a Phase 3 study, has completed, sponsored by Bracco Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.
Primary Outcome
Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs) using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-diagnose (ITD) population. Unit of analysis was the lesion, equivalent to subject, since each subject had a single lesion to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonogr
Interventions
- DRUG SonoVue®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT00829413 record still lists
NCT00829413 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which SonoVue® is the first listed.
NCT00829413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00829413 about?
NCT00829413 is a clinical study titled "SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization". The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinica...
What is the current status of trial NCT00829413?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2010-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00829413?
The interventions under investigation include: SonoVue® (DRUG).
Who is sponsoring clinical trial NCT00829413?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00829413's enrollment target sits among peer trials
353 1028th of 2000 higher than 971 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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