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

Purpose

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	Intervention
Cancer Metastases Liver Neoplasms	Other: Liver MRI with Gdfos Other: Liver MRI with EcGd


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial

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Drug Information available for: Gadofosveset trisodium

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.


Estimated Enrollment:	150
Study Start Date:	August 2013
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: gadobutrol (Gadovist, EcGd)

Arms

Assigned Interventions

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 Name: 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 Name: gadobutrol (Gadovist, EcGd)

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036008

Contacts


Contact: Helen Cheung	416-480-6100 ext 85463	hecheung@sunnybrook.ca

Locations


Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Laurent Milot, MD laurent.milot@sunnybrook.ca
Principal Investigator: Laurent Milot, MD
Sub-Investigator: Helen Cheung, MD
Sub-Investigator: Caitlin McGregor, MD
Sub-Investigator: Calvin Law, MD
Sub-Investigator: Paul Karanicolas, MD

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators


Principal Investigator:	Laurent Milot, MD	Sunnybrook Health Sciences Centre

More Information

Publications:

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.


Responsible Party:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT02036008 History of Changes
Other Study ID Numbers:	153-2013
Study First Received:	October 30, 2013
Last Updated:	January 13, 2014

Keywords provided by Sunnybrook Health Sciences Centre:


Liver metastases MRI Contrast Agents

Additional relevant MeSH terms:


Neoplasm Metastasis Neoplasms, Second Primary Hemangioma Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Neoplasms, Vascular Tissue	Neoplasms by Histologic Type Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Liver Extracts Hematinics

ClinicalTrials.gov processed this record on May 24, 2017