NCT00828607

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

6.9 years

First QC Date

January 23, 2009

Last Update Submit

February 6, 2018

Conditions

Liver Tumors

Keywords

Contrast Enhanced Ultrasound (CEUS)Liver tumorsHepatocellular carcinomaHemangiomaFocal Nodular HyperplasiaHepatic metastases

Outcome Measures

Primary Outcomes (1)

  • Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.

    6-9 months

Secondary Outcomes (1)

  • Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.

    6-9 months

Study Arms (1)

liver mass

The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patient with an unknown liver mass

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Medical centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularHemangiomaFocal Nodular Hyperplasia

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasms, Vascular Tissue

Study Officials

  • Stephanie R Wilson, MD

    Foothills Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor University of Calgary

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

CA(4)