title: A Multicenter MRI Protocol for the Evaluation and Quantification of Deep Vein Thrombosis.
abstract: We evaluated a magnetic resonance venography (MRV) approach with gadofosveset to quantify total thrombus volume changes as the principal criterion for treatment efficacy in a multicenter randomized study comparing edoxaban monotherapy with a heparin/warfarin regimen for acute, symptomatic lower extremities deep vein thrombosis (DVT) treatment. We also used a direct thrombus imaging approach (DTHI, without the use of a contrast agent) to quantify fresh thrombus. We then sought to evaluate the reproducibility of the analysis methodology and applicability of using 3D magnetic resonance venography and direct thrombus imaging for the quantification of DVT in a multicenter trial setting. From 10 randomly selected subjects participating in the edoxaban Thrombus Reduction Imaging Study (eTRIS), total thrombus volume in the entire lower extremity deep venous system was quantified bilaterally. Subjects were imaged using 3D-T1W gradient echo sequences before (direct thrombus imaging, DTHI) and 5 min after injection of 0.03 mmol/kg of gadofosveset trisodium (magnetic resonance venography, MRV). The margins of the DVT on corresponding axial, curved multi-planar reformatted images were manually delineated by two observers to obtain volumetric measurements of the venous thrombi. MRV was used to compute total DVT volume, whereas DTHI was used to compute volume of fresh thrombus. Intra-class correlation (ICC) and Bland Altman analysis were performed to compare inter and intra-observer variability of the analysis. The ICC for inter and intra-observer variability was excellent (0.99 and 0.98, p <0.001, respectively) with no bias on Bland-Altman analysis for MRV images. For DTHI images, the results were slightly lower (ICC = 0.88 and 0.95 respectively, p <0.001), with bias for inter-observer results on Bland-Altman plots. This study showed feasibility of thrombus volume estimation in DVT using MRV with gadofosveset trisodium, with good intra- and inter-observer reproducibility in a multicenter setting.
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai; venkatesh.mani@mssm.edu.
authors.forename: Venkatesh
authors.initials: V
authors.lastname: Mani
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Nadia
authors.initials: N
authors.lastname: Alie
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Sarayu
authors.initials: S
authors.lastname: Ramachandran
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Robson
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Besa
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School.
authors.forename: Gregory
authors.initials: G
authors.lastname: Piazza
authors.affiliation: Daiichi Sankyo Pharma Development.
authors.forename: Michele
authors.initials: M
authors.lastname: Mercuri
authors.affiliation: Daiichi Sankyo Pharma Development.
authors.forename: Michael
authors.initials: M
authors.lastname: Grosso
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Bachir
authors.initials: B
authors.lastname: Taouli
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School.
authors.forename: Samuel Z
authors.initials: SZ
authors.lastname: Goldhaber
authors.affiliation: Department of Radiology, Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai.
authors.forename: Zahi A
authors.initials: ZA
authors.lastname: Fayad
mesh_terms: D003287:Contrast Media; D005682:Gadolinium; D006801:Humans; D007866:Leg / Q000098:blood supply; D018810:Magnetic Resonance Angiography / Q000379:methods*; D009942:Organometallic Compounds; D010388:Pelvis / Q000098:blood supply; D011725:Pyridines / Q000627:therapeutic use*; D015203:Reproducibility of Results; D013844:Thiazoles / Q000627:therapeutic use*; D020246:Venous Thrombosis / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D011725:Pyridines; D013844:Thiazoles; D005682:Gadolinium; C552171:edoxaban; C109932:gadofosveset trisodium