Liver Lesions
Conditions
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).
Interventions
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-administration up to 15 minutes post-administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | For the cases that can be assessed by the blinded readers both pre- and post-contrast, differences were calculated between the Sonazoid™ and SonoVue® groups in the number of lesions detected during whole-liver imaging (post-contrast minus pre-contrast). The differences were also calculated between the Sonazoid™ and SonoVue® groups in the number of lesions (post-contrast minus reference diagnosis) detected during whole-liver imaging. |
| 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 | Confidence in diagnoses from the pre- and post-contrast ultrasound examinations was evaluated based on 4-point scale: 0-Unknown (cannot make a judgement on level of confidence), 1- Not confident (another examination was required), 2- Probable (Would have more confidence if another diagnostic imaging test such as MRI or CT was performed), 3- Definite (Sufficient confidence to the extent that another diagnostic imaging test such as MRI or CT was unnecessary). |
| 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 | The 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. Assessment was performed by 3 blinded readers. |
Countries
China, South Korea, Taiwan
Participant flow
Recruitment details
The study was conducted at 17 centres in China, Korea and Taiwan. A total of 424 participants were enrolled between 11 May 2014 and 9 April 2015.
Pre-assignment details
Participants were randomised in 1:1 ratio to receive either Sonazoid™ or SonoVue®.
Participants by arm
| Arm | Count |
|---|---|
| Sonazoid™ Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. | 218 |
| SonoVue® Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL). | 206 |
| Total | 424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other than specified above | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Technical Problems | 1 | 0 |
Baseline characteristics
| Characteristic | SonoVue® | Total | Sonazoid™ |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 13.77 | 53.4 years STANDARD_DEVIATION 13.22 | 54.5 years STANDARD_DEVIATION 12.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 206 Participants | 424 Participants | 218 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 81 Participants | 162 Participants | 81 Participants |
| Sex: Female, Male Male | 125 Participants | 262 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 218 | 0 / 206 |
| other Total, other adverse events | 0 / 218 | 0 / 206 |
| serious Total, serious adverse events | 0 / 218 | 0 / 206 |
Outcome results
Primary
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.
Time frame: Pre-administration up to 15 minutes post-administration
Population: Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sonazoid™ | 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 | Reader 1 | 18.1 percentage of participants |
| Sonazoid™ | 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 | Reader 2 | 22.1 percentage of participants |
| Sonazoid™ | 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 | Reader 3 | 17.0 percentage of participants |
| SonoVue® | 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 | Reader 1 | 24.2 percentage of participants |
| SonoVue® | 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 | Reader 2 | 14.6 percentage of participants |
| SonoVue® | 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 | Reader 3 | 16.7 percentage of participants |
Secondary
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)
For the cases that can be assessed by the blinded readers both pre- and post-contrast, differences were calculated between the Sonazoid™ and SonoVue® groups in the number of lesions detected during whole-liver imaging (post-contrast minus pre-contrast). The differences were also calculated between the Sonazoid™ and SonoVue® groups in the number of lesions (post-contrast minus reference diagnosis) detected during whole-liver imaging.
Time frame: Pre-administration up to 15 minutes post-administration
Population: Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sonazoid™ | 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) | Post-contrast minus Pre-contrast: Reader 1 | 0.0 Lesions |
| Sonazoid™ | 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) | Post-contrast minus Pre-contrast: Reader 2 | 0.0 Lesions |
| Sonazoid™ | 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) | Post-contrast minus Pre-contrast: Reader 3 | 0.0 Lesions |
| Sonazoid™ | 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) | Post-contrast minus Reference: Reader 1 | 1.0 Lesions |
| Sonazoid™ | 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) | Post-contrast minus Reference: Reader 2 | 0.0 Lesions |
| Sonazoid™ | 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) | Post-contrast minus Reference: Reader 3 | 0.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Reference: Reader 2 | 0.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Pre-contrast: Reader 1 | 0.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Reference: Reader 1 | 1.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Pre-contrast: Reader 2 | -1.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Reference: Reader 3 | 0.0 Lesions |
| SonoVue® | 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) | Post-contrast minus Pre-contrast: Reader 3 | -1.0 Lesions |
Secondary
Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results
Confidence in diagnoses from the pre- and post-contrast ultrasound examinations was evaluated based on 4-point scale: 0-Unknown (cannot make a judgement on level of confidence), 1- Not confident (another examination was required), 2- Probable (Would have more confidence if another diagnostic imaging test such as MRI or CT was performed), 3- Definite (Sufficient confidence to the extent that another diagnostic imaging test such as MRI or CT was unnecessary).
Time frame: Pre-administration up to 15 minutes post-administration
Population: Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Not confident (1 point) | 17 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Probable (2 points) | 113 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Not confident (1 point) | 46 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Unknown (0 points) | 0 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Definite (3 points) | 57 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Probable (2 points) | 86 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Definite (3 points) | 10 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Unknown (0 points) | 0 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Definite (3 points) | 15 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Probable (2 points) | 89 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Not confident (1 point) | 65 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Unknown (0 points) | 0 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Definite (3 points) | 116 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Probable (2 points) | 43 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Not confident (1 point) | 4 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Unknown (0 points) | 0 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Definite (3 points) | 38 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Probable (2 points) | 89 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Not confident (1 point) | 42 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Unknown (0 points) | 0 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Definite (3 points) | 130 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Probable (2 points) | 31 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Not confident (1 point) | 4 Participants |
| Sonazoid™ | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Unknown (0 points) | 0 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Not confident (1 point) | 9 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Definite (3 points) | 11 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Definite (3 points) | 103 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Probable (2 points) | 122 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Not confident (1 point) | 42 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Not confident (1 point) | 36 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Probable (2 points) | 51 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Pre-contrast | Unknown (0 points) | 0 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Probable (2 points) | 36 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Definite (3 points) | 54 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Not confident (1 point) | 4 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Probable (2 points) | 88 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Unknown (0 points) | 1 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Not confident (1 point) | 15 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Post-contrast | Unknown (0 points) | 0 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 1: Post Contrast | Unknown (0 points) | 0 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Unknown (0 points) | 0 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Definite (3 points) | 12 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Definite (3 points) | 36 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Probable (2 points) | 79 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Post-contrast | Definite (3 points) | 117 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Not confident (1 point) | 78 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 3: Pre-contrast | Probable (2 points) | 90 Participants |
| SonoVue® | Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results | Reader 2: Pre-contrast | Unknown (0 points) | 0 Participants |
Secondary
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
The 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. Assessment was performed by 3 blinded readers.
Time frame: Pre-administration up to 15 minutes post-administration
Population: Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sonazoid™ | 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 | Reader 1 | 11.9 percentage of participants |
| Sonazoid™ | 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 | Reader 2 | 16.6 percentage of participants |
| Sonazoid™ | 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 | Reader 3 | 15.8 percentage of participants |
| SonoVue® | 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 | Reader 1 | 21.7 percentage of participants |
| SonoVue® | 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 | Reader 2 | 15.2 percentage of participants |
| SonoVue® | 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 | Reader 3 | 19.1 percentage of participants |