Liver NeoplasmsPhase 3NCT00829413

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

A Phase 3 study testing SonoVue® in people with Liver Neoplasms, run by Bracco Diagnostics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Neoplasms
What is being tested?: SonoVue®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 353 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Jul 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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®.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bracco Diagnostics Inc.
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: Characterization Of Focal Liver Lesions With Sonovue®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard

Read the detailed description

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Conditions: Liver Neoplasms
Being tested: SonoVue®
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SonoVue®Drug
Also called sulfur hexafluoride microbubbles
SonoVue (2.4 mL)

Study groups in NCT00829413
Study group	Role	What they receive
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. Receives: Drug: SonoVue®

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 24 hours to 6 months

Secondary outcomes (6)

Accuracy: Percentage of True Positive and True Negative Among All Lesions
Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and 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 positive: subject with a target lesion characterized as malignant by both ultrasonography and truth standard.
True negative: subject with a target lesion characterized as benign by both ultrasonography and 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 and true negative lesions/number of total lesions per truth standard) x 100.
Measured: 24 hours to 6 months
Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound
Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of 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 positive: subject with a target lesion characterized as malignant by both ultrasonography and 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 ultrasound) x 100.
Measured: 24 hours to 6 months
Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound
Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of 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.
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 ultrasound) x 100.
Measured: 24 hours to 6 months
Specific Diagnosis of Malignant FLLs
SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant 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.
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 correctly characterized lesions/number of lesions per truth standard) x 100.
Measured: 24 hours to 6 months
Specific Diagnosis of Benign FLLs
SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis 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.
Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.
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 correctly characterized lesions/number of lesions per truth standard) x 100.
Measured: 24 hours to 6 months
Inter-reader Agreement
Kappa statistic based on assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately and computation for the percentage agreement within two categories: "3 out of 3 readers agree" and "2 out of 3 readers agree".
Measured: 24 hours to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jul 2013

First posted27 Jan 2009 (estimated)
Study startJun 2010
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 353 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00829413
Sponsor's protocol ID: BR1-130
Status last verified: Nov 2017
First submitted: 26 Jan 2009
Last updated: 3 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization Of Focal Liver Lesions With Sonovue®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Unenhanced Ultrasound Imaging Using Histology Or Combined Imaging/Clinical Data As Truth Standard
ClinicalTrials.gov ID: NCT00829413
Acronym / sponsor ID: BR1-130
Conditions: Liver Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 353 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 27 Jan 2009 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients who received SonoVue	Other	Drug: SonoVue®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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SonoVue®Also: sulfur hexafluoride microbubblesSonoVue (2.4 mL)	Drug	Patients who received SonoVue

Primary outcome

Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard
Time frame: 24 hours to 6 months
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
Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard'
Time frame: 24 hours to 6 months
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.

6 secondary outcomes

Accuracy: Percentage of True Positive and True Negative Among All Lesions
Time frame: 24 hours to 6 months
Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound
Time frame: 24 hours to 6 months
Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound
Time frame: 24 hours to 6 months
Specific Diagnosis of Malignant FLLs
Time frame: 24 hours to 6 months
Specific Diagnosis of Benign FLLs
Time frame: 24 hours to 6 months
Inter-reader Agreement
Time frame: 24 hours to 6 months

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Safety Population	353	259

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

Time frame: 24 hours to 6 months. Number (95% Confidence Interval). Unit: Percentage of true positive lesions

Measure	Offsite Reader 1 UE-US n = 119	Offsite Reader 1 SonoVue CE-US n = 119	Offsite Reader 2 UE-US n = 119	Offsite Reader 2 SonoVue CE-US n = 119	Offsite Reader 3 UE-US n = 119	Offsite Reader 3 SonoVue CE-US n = 119
Value	48.7 (39.8 to 57.7)	86.6 (80.4 to 92.7)	35.3 (26.7 to 43.9)	75.6 (67.9 to 83.3)	16.0 (9.4 to 22.5)	91.6 (86.6 to 96.6)

Offsite Reader 1 UE-US vs Offsite Reader 1 SonoVue CE-US: Difference in Sensitivity (%): 37.8 (95% CI 27.4 to 48.2), p <.0001, McNemar
Offsite Reader 2 UE-US vs Offsite Reader 2 SonoVue CE-US: Difference in Sensitivity (%): 40.3 (95% CI 30.4 to 50.3), p <.0001, McNemar
Offsite Reader 3 UE-US vs Offsite Reader 3 SonoVue CE-US: Difference in Sensitivity (%): 75.6 (95% CI 67.9 to 83.3), p <.0001, McNemar

Population analysed: Among 259 ITD subjects, 119 were malignant by truth standard and were included for sensitivity.

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

Time frame: 24 hours to 6 months. Number (95% Confidence Interval). Unit: Percentage of true benign lesions

Measure	Offsite Reader 1 UE-US n = 140	Offsite Reader 1 SonoVue CE-US n = 140	Offsite Reader 2 UE-US n = 140	Offsite Reader 2 SonoVue CE-US n = 140	Offsite Reader 3 UE-US n = 140	Offsite Reader 3 SonoVue CE-US n = 140
Value	62.9 (54.9 to 70.9)	70.7 (63.2 to 78.3)	54.3 (46.0 to 62.5)	82.9 (76.6 to 89.1)	22.1 (15.3 to 29.0)	72.9 (65.5 to 80.2)

Offsite Reader 1 UE-US vs Offsite Reader 1 SonoVue CE-US: Difference in Specificity (%): 7.9 (95% CI -2.4 to 18.2), p = 0.1380, McNemar
Offsite Reader 2 UE-US vs Offsite Reader 2 SonoVue CE-US: Difference in Specificity (%): 28.6 (95% CI 19.7 to 37.5), p <.0001, McNemar
Offsite Reader 3 UE-US vs Offsite Reader 3 SonoVue CE-US: Difference in Specificity (%): 50.7 (95% CI 42.0 to 59.5), p <.0001, McNemar

Population analysed: Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard and were were included for specificty.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the time of signing the Informed Consent Form through 7 days after SonoVue administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	4 of 340 (1.2%)	45 of 340 (13.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alberto Spinazzi, M.D. study director

Bracco Diagnostics, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SonoVue® in people with Liver Neoplasms, run by Bracco Diagnostics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard (time frame: 24 hours to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.