NCT02036008

Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Metastases
• Liver Neoplasms

Interventions

Type	Name	Description
OTHER	Liver MRI with Gdfos	Participants will receive Gdfos at a dose of 10 mL of 0.25mmol/mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush. Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase. This study will be performed within 4 weeks of the MRI study with EcGd.
OTHER	Liver MRI with EcGd	Participants will receive a liver MRI with EcGd as per clinical institutional protocol. Participants will receive EcGd at a dose of 0.1 mL/kg body mass up to 10 mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush. Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase. Additional noncontrast images will be obtained as per institutional protocol, including diffusion weighted imaging, in/out of phase imaging, and T2 weighted imaging.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2014-01-14
• Last updated: 2014-01-14

Locations

1 site across 1 country: Canada