Status:
COMPLETED
An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
Lead Sponsor:
GE Healthcare
Conditions:
Liver Lesions
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Participants may be included in the study if they meet all of the following 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
- 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
Key Trial Info
Start Date :
May 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2015
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT03335566
Start Date
May 11 2014
End Date
April 9 2015
Last Update
October 31 2018
Active Locations (18)
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1
Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing
Dongcheng, Beijing Municipality, China, 100730
2
Chinese PLA General Hospital, No. 28 Fuxing Road
Haidan, Beijing Municipality, China, 100853
3
Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong
Xicheng, Beijing Municipality, China, 100032
4
The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road
Guangzhou, Guangdong, China, 510080