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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00829413 |
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.
Condition | Intervention | Phase |
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Liver Neoplasms |
Drug: SonoVue® |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Characterization Of Focal Liver Lesions With Sonovue®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard |
Estimated Enrollment: | 156 |
Study Start Date: | December 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1- unenhanced: No Intervention
Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion will be performed using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma.
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2-Sonovue Enhanced: Active Comparator
SonoVue®-enhanced ultrasound will be performed, according to the procedures described in Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma. SonoVue® (2.4 mL) will be administered as a bolus injection in a peripheral vein.
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Drug: SonoVue®
SonoVue (2.4 mL)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.
Contact: Carmela Houston-Henry | 516-333-8230 ext 3350 | carmela.houston@diag.bracco.com |
United States, New Jersey | |
Bracco Diagnostics Inc. | |
Princeton, New Jersey, United States, 08540 |
Responsible Party: | Bracco Diagnostics ( Carmela Houston-Henry, Sr. Manager Corporate Clinical Research ) |
Study ID Numbers: | BR1-130 |
Study First Received: | January 26, 2009 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00829413 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Neoplasms |
Liver Neoplasms Liver Diseases Neoplasms |
Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |