Clinical trial NCT02036008: Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
Official title: Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Metastases
Liver Neoplasms
Keywords: Liver metastases
MRI
Contrast Agents
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard
timeFrame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.
Secondary outcomes:
measure: Inter-reader variability for EcGd-enhanced vs. Gdfos-enhanced imaging
timeFrame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.
measure: Reader diagnostic accuracy of EcGd-enhanced imaging vs. Gdfos-enhanced imaging compared to gold standard (subgroup analysis for small lesions less than or equal to 1cm)
timeFrame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Laurent Milot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milot L, Haider M, Foster L, McGregor C, Law C. Gadofosveset trisodium in the investigation of focal liver lesions in noncirrhotic liver: Early experience. J Magn Reson Imaging. 2012 Sep;36(3):738-42. doi: 10.1002/jmri.23650. Epub 2012 Apr 5.