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

NCT03335566 | Completed Phase 3 Results

• 1 other identifier: GE-045-002
• Study Type: interventional
• Target: 424
• Locations: 3 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Accuracy Improvement in Post-Contrast Versus Pre-Contrast Ultrasound (US) Examination for Diagnosis of the Target Lesion as Malignant or Benign Against the Reference Diagnosis (RD)/Standard of Truth

  Accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants, multiplied by 100. Assessments were done by 3 blinded readers. Efficacy population which included all participants who received Sonazoid™ or SonoVue®, for whom pre-contrast \& post-contrast images were recorded, \& for whom there was a reference standard contrast-enhanced computed tomography (CECT)/contrast-enhanced magnetic resonance imaging (CE-MRI) examination or biopsy.

  Pre-administration up to 15 minutes post-administration

Secondary Outcomes (3)

• Number of Lesions Detected by Post-Contrast US Relative to Number of Lesions Detected by Pre-Contrast US (Both by Blinded Readers[BR]) and Number of Lesions Detected by Post-Contrast US (by BR) Relative to Number of Lesions Detected by RD (Investigators)

  Pre-administration up to 15 minutes post-administration

• Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results

  Pre-administration up to 15 minutes post-administration

• Percentage of Participants With Accuracy Improvement in Post-contrast Versus Pre-contrast Ultrasound Examination for Lesion-Specific Diagnoses of the Target Lesion Against the Reference Diagnosis/Standard of Truth

  Pre-administration up to 15 minutes post-administration

Study Arms (2)

Sonazoid™

EXPERIMENTAL

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

Drug: Sonazoid™

SonoVue®

ACTIVE COMPARATOR

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

Drug: SonoVue®

Interventions

Sonazoid™ DRUG

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

Sonazoid™

SonoVue® DRUG

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

SonoVue®

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (18)

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

Dongcheng, Beijing Municipality, 100730, China

Location

Chinese PLA General Hospital, No. 28 Fuxing Road

Haidan, Beijing Municipality, 100853, China

Location

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

Xicheng, Beijing Municipality, 100032, China

Location

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

Guangzhou, Guangdong, 510080, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

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

Hongkou, Shanghai Municipality, 200080, China

Location

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

Songjiang, Shanghai Municipality, 201620, China

Location

Zhongshan Hospital Fudan University, No. 180 Fenglin Road

Xuhui, Shanghai Municipality, 200032, China

Location

Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road

Xuhui, Shanghai Municipality, 200040, China

Location

Shanghai Sixth Hospital, No. 600 Yishan Road

Xuhui, Shanghai Municipality, 200233, China

Location

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

Zhabei, Shanghai Municipality, 200072, China

Location

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

Seoul, 110-744, South Korea

Location

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

Seoul, 137-701, South Korea

Location

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

Douliu, Yunlin County, Taiwan

Location

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

Taipei, 100, Taiwan

Location

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

Taipei, 10449, Taiwan

Location

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

Taipei, 10650, Taiwan

Location

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

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Sonazoid; contrast agent BR1

Results Point of Contact

• Title: Francois Tranquart, M.D, PhD
• Organization: GE Healthcare

francois.tranquart@ge.com

011-44-1494-543037

Study Officials

• Francois Tranquart, MD, PhD

  GE Healthcare

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: May 11, 2014
• Primary Completion: April 9, 2015
• Study Completion: April 9, 2015
• Last Updated: October 31, 2018
• Results First Posted: August 27, 2018

Record last verified: 2018-10

Locations

KR (2); TW (5); CN (11)