Liver TumorsNCT00828607
Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses
An observational study of Liver Tumors, run by Foothills Medical Centre at 4 sites in Canada.
Trial summary
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Tumors
- How many people
- 250 participants
- Where
- 4 sitesCanada
- Study dates
- Jan 2009to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with an unknown liver mass
Who may be able to join
- An incidental liver mass amenable to US evaluation
- Undiagnosed liver mass
- Mass threshold size is 2.5 cm
- Source of subjects:
- Liver mass found on conventional institutional US
- Liver mass detected on CT and MRI that remain uncategorized
- Referral of patient with a liver mass following detection in outside institution.
- Confirmatory CT or MRI performed within 60 days of initial scan according to the institutional protocols
Who cannot join
- Any known pre existing mass
- Pregnancy
- Severe or unstable cardiac disease, including angina, congestive heart failure, or arrhythmias
- Severe COPD
- Pulmonary hypertension
- Bidirectional shunts
- Transient right to left shunts
- Known hypersensitivity to Definity or any of its components
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
Sunnybrook Medical centre
Toronto, Ontario, M4N 3M5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
Read the detailed description
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
- Conditions
- Liver Tumors
- Keywords
- Contrast Enhanced Ultrasound (CEUS), Liver tumors, Hepatocellular carcinoma, Hemangioma, Focal Nodular Hyperplasia, Hepatic metastases
- Medical subject headings
- Carcinoma, Hepatocellular, Hemangioma, Focal Nodular Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver mass | The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
Measured: 6-9 months
Secondary outcomes (1)
Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foothills Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver General Hospital, London Health Sciences Centre, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Principal investigator, Stephanie R Wilson, MD, Foothills Medical Centre
- Investigators
- Stephanie R Wilson, MD, Principal investigator, Foothills Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828607
- Sponsor's protocol ID
- (Ethics ID: 21295)
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2009
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)
- ClinicalTrials.gov ID
- NCT00828607
- Acronym / sponsor ID
- (Ethics ID: 21295)
- Conditions
- Liver Tumors
- Keywords
- Contrast Enhanced Ultrasound (CEUS), Liver tumors, Hepatocellular carcinoma, Hemangioma, Focal Nodular Hyperplasia, Hepatic metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Foothills Medical CentreUniversity, hospital or other
- Collaborators
- Vancouver General Hospital, London Health Sciences Centre, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Jan 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
Detailed description
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver mass | – | –The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with an unknown liver mass
Key inclusion criteria (8 listed)
- An incidental liver mass amenable to US evaluation
- Undiagnosed liver mass
- Mass threshold size is 2.5 cm
- Source of subjects:
- Confirmatory CT or MRI performed within 60 days of initial scan according to the institutional protocols
Key exclusion criteria (8 listed)
- Any known pre existing mass
- Pregnancy
- Severe or unstable cardiac disease, including angina, congestive heart failure, or arrhythmias
- Severe COPD
- Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
Time frame: 6-9 months
1 secondary outcome
Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
Time frame: 6-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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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.
Stephanie R Wilson, MD principal investigator
Foothills Medical Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumors, run by Foothills Medical Centre at 4 sites in Canada.
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 8 inclusion and 8 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2018.