Gadofosveset trisodium

Overview

Gadofosveset trisodium is an intravenous contrast agent used with magnetic resonance angiography(MRA), which is a non-invasive way of imaging blood vessels. The agent allows for the vascular system to be imaged more clearly by the MRA. In this way, gadofosveset trisodium is used to help diagnose certain disorders of the heart and blood vessels.

Background

Indication

Gadofosveset trisodium is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

Associated Conditions

Aortoiliac Occlusive Disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease	2016/04/26	NCT02752191	Phase 4	Completed	Paul Finn
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer	2014/09/17	NCT02243059	Phase 4	Withdrawn	Maastricht University Medical Center
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	2012/11/06	NCT01721785	N/A	Completed	Maastricht University Medical Center
Nodal Staging in Breast Cancer With MRL	2012/06/01	NCT01609920	Not Applicable	Terminated	Maastricht University Medical Center
Gadofosveset for Axillary Staging in Breast Cancer Patients	2011/09/21	NCT01437865	Not Applicable	Completed	Maastricht University Medical Center
Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants	2011/09/09	NCT01431300	Not Applicable	Completed	Duke University
Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	2010/07/20	NCT01165892	N/A	Completed	Washington University School of Medicine
Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist	2008/04/29	NCT00668824	Phase 4	UNKNOWN	Guy's Hospital
Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent	2006/12/25	NCT00415805	Phase 3	Completed	Bracco Diagnostics, Inc
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases	2006/09/13	NCT00375830	Phase 2	Completed	Stanford University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Additive Formula 3	Terumo BCT, Ltd	14537-833	INTRAVENOUS	0.59 g in 100 mL	12/15/2021
Anticoagulant Sodium Citrate	CSL Plasma Inc.	81839-782	INTRAVENOUS	40 mg in 1 mL	5/5/2022
Haemonetics Anticoagulant Sodium Citrate	Haemonetics Corporation	57826-420	EXTRACORPOREAL	40 mg in 1 mL	2/2/2021
Oral Citrate Solution	Brandywine Pharmaceuticals, LLC	71321-604	ORAL	490 mg in 5 mL	2/19/2024
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)	Terumo Corporation	53877-001	INTRAVENOUS	26.3 g in 1000 mL	12/7/2018
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)	Terumo Corporation	53877-001	INTRAVENOUS	26.3 g in 1000 mL	12/7/2018
Additive Formula 3	Terumo BCT, Ltd	14537-828	INTRAVENOUS	0.59 g in 100 mL	7/18/2018
ACD A	Terumo BCT, Ltd.	14537-817	INTRAVENOUS	2.2 g in 100 mL	8/31/2017
CPDA-1	Fenwal, Inc.	0942-9394	INTRAVENOUS	1.66 g in 63 mL	11/1/2022
CPDA-1	Fenwal, Inc.	0942-6326	INTRAVENOUS	1.84 g in 70 mL	8/27/2014

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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