Journal article
MR angiography of aortoiliac occlusive disease : A phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325
Radiology, Vol.236(3), pp.825-833
2005
DOI: 10.1148/radiol.2363040577
PMID: 16020554
Abstract
PURPOSE: To evaluate prospectively the safety and effectiveness of aortoiliac magnetic resonance (MR) angiography enhanced with MS-325 (gadofosveset trisodium) at a dose of 0.03 mmol/kg; effectiveness was defined as accuracy relative to the reference standard, conventional angiography.
MATERIALS AND METHODS: Study was approved by institutional review boards of participating institutions, and required national approvals were obtained. Study protocol conformed to Good Clinical Practice guidelines, and informed patient consent was obtained. Patients with known or suspected peripheral vascular disease received 0.03 mmol/kg MS-325 for aortoiliac MR angiography. They were also examined with conventional angiography. MS-325–enhanced MR was evaluated for safety and effectiveness. Along with unenhanced two-dimensional time-of-flight MR angiography, it was compared with conventional angiography for presence of vascular stenosis. Student t tests were used to identify significant improvement in diagnostic sensitivity, specificity, and accuracy, as well as quantitative characterization of stenoses by three blinded readers. Correlations between readers of conventional angiograms were calculated and compared with MR results.
RESULTS: In 174 patients, MS-325–enhanced MR angiography showed significant improvement (P ≤ .001) in sensitivity, specificity, and accuracy for diagnosis of clinically significant (≥50%) stenosis, compared with unenhanced MR. For all readers, areas under the receiver operating characteristic curve for both quantitative and qualitative measures of significant disease increased (P < .001) for MS-325–enhanced MR compared with time-of-flight MR. All readers also expressed higher confidence in diagnosis (P < .001) and found fewer images uninterpretable with MS-325 enhancement. All measures of interpretation accuracy approached corresponding measures of correlation between readers of conventional angiograms. Incidence of severe and serious adverse events with MS-325 was low. No patients were withdrawn from study due to adverse events or abnormalities in laboratory results. There were no clinically important trends in findings at hematology, blood chemistry, urinalysis, electrocardiography, or physical examination.
CONCLUSION: MR angiography with MS-325 provides significant improvement in effectiveness over unenhanced MR (and minimal and transient side effects) at a dose of 0.03 mmol/kg and was safe and effective for MR evaluation of patients with aortoiliac occlusive disease.
Details
- Title: Subtitle
- MR angiography of aortoiliac occlusive disease : A phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325
- Creators
- Mathias GOYEN - Department of Diagnostic and Interventional Radiology, University Hospital Essen, Hufelandstrasse 55, 45147 Essen, GermanyMark EDELMAN - Rush North Shore Medical Center, Skokie, Ill, United StatesE Kent Yucel - Brigham and Women's Hospital, Boston, Mass, United StatesKohkan SHAMSI - Berlex Labora tories, Montville, NJ, United StatesRobert M WEISSKOFF - EPIX Medical, Cambridge, Mass, United StatesPierre PERREAULT - Hôpital St Luc, Montreal, Quebec, CanadaElaine O'RIORDAN - London Health Sciences Center, London, Ontario, CanadaHernan BERTONI - Hospital Italiano, Buenos Aires, ArgentinaJames TAYLOR - Royal Adelaide HospitalDaniel SIRAGUSA - University of Florida/Shands-Jacksonville, Jacksonville, Fla, United StatesMelhem SHARAFUDDIN - University of Iowa Hospital and Clinics, Iowa City, Iowa, United StatesEmile R MOHLER - University of Pennsylvania School of Medicine, Philadelphia, Pa, United StatesRobert BREGER - St Luke's Medical Center, Milwaukee, Wis, United States
- Resource Type
- Journal article
- Publication Details
- Radiology, Vol.236(3), pp.825-833
- Publisher
- Radiological Society of North America; Oak Brook, IL
- DOI
- 10.1148/radiol.2363040577
- PMID
- 16020554
- ISSN
- 0033-8419
- eISSN
- 1527-1315
- Language
- English
- Date published
- 2005
- Academic Unit
- Radiology; Surgery
- Record Identifier
- 9984051543002771
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