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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02036008

Collaborator

(none)

150

Enrollment

Location

Arm

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer Metastases Liver Neoplasms	Other: Liver MRI with Gdfos Other: Liver MRI with EcGd	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Liver MRI with EcGd and with Gdfos All participants will receive two contrast-enhanced MRI studies of the liver: one with gadofosveset trisodium (Gdfos) and one with gadobutrol (EcGd) at a dose of 0.1 mL/kg body mass up to 10 mL.	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 Names: Gadofosveset trisodium (Gdfos) 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. Other Names: gadobutrol (Gadovist, EcGd)

Arm

Intervention/Treatment

Other: Liver MRI with EcGd and with Gdfos

All participants will receive two contrast-enhanced MRI studies of the liver: one with gadofosveset trisodium (Gdfos) and one with gadobutrol (EcGd) at a dose of 0.1 mL/kg body mass up to 10 mL.

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 Names:

Gadofosveset trisodium (Gdfos)

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.

Other Names:

gadobutrol (Gadovist, EcGd)

Outcome Measures

Primary Outcome Measures

Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard [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.]
Three blinded radiologists of different training levels will read the MRI liver studies done using Gdfos and EcGd and the results of this will be compared to a gold standard (either pathology from surgery or biopsy or long-term follow-up). The diagnostic accuracy of Gdfos vs. EcGd will be compared using area under receiver operating characteristic (ROC) curves (with correction for correlation and clustering).

Secondary Outcome Measures

Inter-reader variability for EcGd-enhanced vs. Gdfos-enhanced imaging [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.]
Three blinded radiologists of different training levels will read the MRI liver studies done using Gdfos and EcGd and the results of this will be compared to a gold standard (either pathology from surgery or biopsy or long-term follow-up). The difference in accuracy will be compared between readers using kappa statistics.
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) [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.]
Subgroup analysis for small lesions. The same analysis will be done with only a subgroup of small lesions.