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

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Liver Neoplasms; Metastases; Cancer

Treatments: Other: Liver MRI with Gdfos; Other: Liver MRI with EcGd

Study type: Interventional

Funder types: Other

Identifiers

NCT02036008

153-2013

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 1 patient group

Liver MRI with EcGd and with Gdfos

Other group

Description:

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.

Treatment:

Other: Liver MRI with EcGd

Other: Liver MRI with Gdfos