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NCT00788697 · ClinicalTrials.gov registry record · Phase 3
SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization
A Phase 3 study of Liver Neoplasms, sponsored by Bracco Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 349
- Enrollment target
- 1
- Study location
NCT00788697: Completed Phase 3 study of Liver Neoplasms, sponsored by Bracco Diagnostics.
NCT00788697 is a Phase 3 study of Liver Neoplasms that has completed, run by Bracco Diagnostics. The registered enrollment target is 349 participants, below the 439-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (21% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00788697, a Phase 3 study of Liver Neoplasms, has completed, sponsored by Bracco Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 349 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/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 the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by bo
Conditions Studied
Interventions
- DRUG SonoVue-enhanced ultrasound
- OTHER Unenhanced ultrasound
Study Locations (1)
New Jersey
- Bracco Diagnostics Inc - Princeton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT00788697 record still lists
NCT00788697 is an interventional study that assigns participants to a tested intervention. The registered 349 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Liver Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which SonoVue-enhanced ultrasound is the first listed.
NCT00788697 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00788697 about?
NCT00788697 is a clinical study titled "SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization". The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.
What is the current status of trial NCT00788697?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2009-09. Estimated completion is 2013-07.
What conditions does trial NCT00788697 study?
This clinical trial studies the following conditions: Liver Neoplasms.
What interventions are being tested in trial NCT00788697?
The interventions under investigation include: SonoVue-enhanced ultrasound (DRUG), Unenhanced ultrasound (OTHER).
Who is sponsoring clinical trial NCT00788697?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00788697 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00788697's enrollment target sits among peer trials
349 2nd of 14 the highest of 14 other Liver Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Neoplasms 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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