Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
Conditions
Cancer - Metastases - Liver Neoplasms
Conditions: official terms
Hemangioma - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Liver metastases, MRI, Contrast Agents
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Intervention
Name: Liver MRI with Gdfos Type: Other
Name: Liver MRI with EcGd Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver metastases compared to the standard agent gadobutrol (EcGd, Gadovist).
Detailed Description
The proposed study will be a single centre, prospective trial comparing the sensitivity and specificity of using Gadofosveset Trisodium (Gdfos, Ablavar) as the MRI contrast agent as compared to gadobutrol (EcGd, Gadovist).

The study population will include cancer patient's referred for an MRI study of the liver to rule out metastases. Those who meet the inclusion/exclusion criteria will their routine (clinical) MRI of the liver with EcGd. They will also receive an additional MRI with Gdfos within 4 weeks of the original study.

The patient data will be anonymized and the imaging will be read by radiologists and radiology residents and comparison will be made between the diagnostic accuracy of the EcGd-enhanced study and the Gdfos-enhanced study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- known cancer

- referred for MRI of liver to rule out metastases

- has focal liver lesions

- age > 18 yo

Exclusion Criteria:

- contraindication to MRI or MR contrast agents

- pregnancy

- unable to obtain all sequences and/or acceptable quality imaging
Location
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Laurent Milot, MD - laurent.milot@sunnybrook.ca
Start Date
August 2013
Completion Date
July 2015
Sponsors
Sunnybrook Health Sciences Centre
Source
Sunnybrook Health Sciences Centre
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page