Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses

Foothills Medical Centre

Status: Completed

Conditions: Liver Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT00828607

(Ethics ID: 21295)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

250 participants in 1 patient group

liver mass

Description:

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