Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vancouver General Hospital | OTHER |
| London Health Sciences Centre | OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liver mass | The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. | 6-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. | 6-9 months |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
Not provided
Not provided
Any patient with an unknown liver mass
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie R Wilson, MD | Foothills Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada | ||
| London Health Sciences Centre, University Hospital |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006391 | Hemangioma |
| D020518 | Focal Nodular Hyperplasia |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
| London |
| Ontario |
| N6A 5A5 |
| Canada |
| Sunnybrook Medical centre | Toronto | Ontario | M4N 3M5 | Canada |
| Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009383 | Neoplasms, Vascular Tissue |