An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging

NCT ID: NCT03335566

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-11
• Study Completion Date: 2015-04-09

Brief Summary

The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).

Conditions

Liver Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sonazoid™

Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.

Group Type: EXPERIMENTAL

Sonazoid™

Intervention Type: DRUG

Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.

SonoVue®

Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).

Group Type: ACTIVE_COMPARATOR

SonoVue®

Intervention Type: DRUG

Single Dose of SonoVue® 2.4 mL as I.V. injection.

Interventions

Sonazoid™

Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.

Intervention Type: DRUG

SonoVue®

Single Dose of SonoVue® 2.4 mL as I.V. injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant has at least 1 untreated focal liver lesions (FLL) but =<8 lesions (excluding cysts) <10 centimeter (cm) in diameter confirmed in a diagnostic examination performed in the past month (or past 3 months if lesion is benign) that can be visualised by non- contrast-enhanced (CE) ultrasound
• Participant has had a dynamic CE-computed tomography (CE-CT) or CE-magnetic resonance imaging (CE-MRI) examination within the past month or is scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/will be available. (This inclusion criterion does not apply for participants enrolled as training cases. Investigators will be asked to submit standard of truth/ reference diagnosis for training cases whenever possible, since the cases may be used for training and testing the blinded readers prior to the blinded read)
• Participant is a 20- to 80-year-old inpatient or outpatient referred for an ultrasound examination of the liver
• Participant is able and willing to comply with study procedures and will give their signed and dated informed consent
• The participant, if female, is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration), are negative

Exclusion Criteria

• The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)
• The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days
• The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy
• The participant is participating in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
• The participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock)
• The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®
• The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination
• The participant has undergone or plans to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, magnetic resonance imaging (MRI) contrast agent or another ultrasound contrast agent) within the 24 hours before or after this examination
• The participant is considered to be unsuitable to participate in the study by the investigator
• The participant is known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure >90 millimeter of mercury (mmHg) or uncontrolled systemic hypertension
• The participant has a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram [ECG], laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
• The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
• The participant has known thrombosis within the liver, portal, or mesenteric veins

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Tranquart, MD, PhD

Role: STUDY_CHAIR

GE Healthcare

Locations

Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing

Dongcheng, Beijing Municipality, China

Chinese PLA General Hospital, No. 28 Fuxing Road

Haidan, Beijing Municipality, China

Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong

Xicheng, Beijing Municipality, China

The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road

Guangzhou, Guangdong, China

Shanghai First Hospital, North Campus: No. 100 Haining Road

Hongkou, Shanghai Municipality, China

Shanghai First Hospital, South Campus: No.650 New Songjiang Road

Songjiang, Shanghai Municipality, China

Zhongshan Hospital Fudan University, No. 180 Fenglin Road

Xuhui, Shanghai Municipality, China

Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road

Xuhui, Shanghai Municipality, China

Shanghai Sixth Hospital, No. 600 Yishan Road

Xuhui, Shanghai Municipality, China

Shanghai Tenth People's Hospital, No. 301 Yanchang Middle Road

Zhabei, Shanghai Municipality, China

Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu

Seoul, , South Korea

Seoul St Mary's Hospital, 222 Banpo-daero, Seocho-gu

Seoul, , South Korea

National Taiwan University Hospital - Yunlin Branch, No. 579, Sec. 2 Yunlin Road

Douliu, Yunlin County, Taiwan

National Taiwan University Hospital, No. 7 Chung-Shan South Road

Taipei, , Taiwan

Mackay Memorial Hospital, No. 92, Sec. 2 Zhongshan N. Road

Taipei, , Taiwan

Cathay General Hospital, No. 280 Jen-Ai Road, Sec. 4

Taipei, , Taiwan

Taipei Veterans General Hospital, No. 201 Shih-Pai Road, Sec. 2

Taipei, , Taiwan

Countries

China; South Korea; Taiwan

Other Identifiers

GE-045-002

Identifier Type: OTHER

Identifier Source: secondary_id

GE-045-002

Identifier Type: -

Identifier Source: org_study_id