Recruiting

Gadofosveset Trisodium

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02036008

Conditions

Cancer

Metastases

Liver Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liver MRI with Gdfos

Liver MRI with EcGd

Study Details

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).

Conditions

Cancer

Metastases

Liver Neoplasms

Study ID

NCT02036008

Start date

Aug, 2013

Status verified date

Jan, 2014

Completion date

Jul, 2015

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Laurent Milot, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 14, 2014

Last verified

Jan, 2014

Keywords

  • Liver metastases
  • MRI
  • Contrast Agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2014-01-14.