SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization

NCT00829413 | Completed Phase 3 Results

• 1 other identifier: BR1-130
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (2)

• Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard

  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 ultrasonography and the truth standard. Truth standard: CE-CT and/or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100

  24 hours to 6 months

• Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard'

  Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the 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 negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard. Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100.

  24 hours to 6 months

Secondary Outcomes (6)

• Accuracy: Percentage of True Positive and True Negative Among All Lesions

  24 hours to 6 months

• Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound

  24 hours to 6 months

• Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound

  24 hours to 6 months

• Specific Diagnosis of Malignant FLLs

  24 hours to 6 months

• Specific Diagnosis of Benign FLLs

  24 hours to 6 months

Study Arms (1)

Patients who received SonoVue

OTHER

Patients with at least one target lesions requiring work-up for characterization to undergo * Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma; * SonoVue-enhanced ultrasound of the target lesion (CE-US):procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and * Truth standard 2.4 mL of sulfur hexafluoride microbubbles (SonoVue®) will be administered as a bolus injection in a peripheral vein.

Drug: SonoVue®

Interventions

SonoVue® DRUG

SonoVue (2.4 mL)

Also known as: sulfur hexafluoride microbubbles

Patients who received SonoVue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female.
• Provides written Informed Consent and is willing to comply with protocol requirements.
• Is at least 18 years of age.
• Has at least 1 FLL (target lesion) requiring work-up for characterization. Target lesions may include those:
• Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects with known history of malignancy.
• Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR
• In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.

You may not qualify if:

• Has an acoustic window insufficient for adequate ultrasound examination of the liver.
• Has a FLL that cannot be identified with unenhanced ultrasound.
• Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
• Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
• Has previously been enrolled in and completed this study.
• Known right to left cardiac shunt, bidirectional or transient.
• Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
• Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
• Has received an investigational compound within 30 days before admission into this study.
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
• Is determined by the Investigator that the subject is clinically unsuitable for the study.
• Is a pregnant or lactating female. Exclude the possibility of pregnancy by:
• 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.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics Inc.

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Maria Luigia Storto, MD Executive Director X-Ray and Ultrasound Medical Affairs
• Organization: Bracco Diagnostics Inc.

MariaLuigia.Storto@diag.bracco.com

(609) 514-2200

Study Officials

• Alberto Spinazzi, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 3, 2018
• Results First Posted: August 3, 2018

Record last verified: 2017-11

Locations

US (1)