Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine
| Autor: | Thomas Jahnke, Richard Coulden, P.J. Schaefer, Hans B. Gehl, Montserrat Bret-Zurita, Joerg W. Oestmann, Ramiro Méndez, Armin Huber, F. Boudghene, Dominik Weishaupt, Michel Nonent, Renate Hammerstingl, José Luis Caniego, Jesus C. Pueyo, Siegfried Thurnher, H J Brambs |
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| Přispěvatelé: | Department of Diagnostic Radiology, University Hospital of Schleswig-Holstein, Département de radiologie [Brest] (DR - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO) |
| Rok vydání: | 2006 |
| Předmět: |
Gadolinium DTPA
Male Contrast Media MESH: Magnetic Resonance Angiography 030218 nuclear medicine & medical imaging 0302 clinical medicine MESH: Aged 80 and over Abdomen MESH: Double-Blind Method Prospective Studies Prospective cohort study MESH: Aged Aged 80 and over MESH: Middle Aged MESH: Arterial Occlusive Diseases medicine.diagnostic_test MESH: Iliac Artery Middle Aged MESH: Predictive Value of Tests 3. Good health medicine.anatomical_structure 030220 oncology & carcinogenesis Predictive value of tests Female Radiology medicine.drug Adult medicine.medical_specialty MESH: Gadolinium DTPA Arterial Occlusive Diseases MESH: Imaging Three-Dimensional MESH: Abdomen Iliac Artery Sensitivity and Specificity 03 medical and health sciences Imaging Three-Dimensional Double-Blind Method Predictive Value of Tests MESH: Contrast Media medicine Humans Radiology Nuclear Medicine and imaging MESH: Angiography Digital Subtraction Aged MESH: Humans business.industry Gadodiamide Angiography Digital Subtraction Magnetic resonance imaging MESH: Adult medicine.disease MESH: Male MESH: Prospective Studies MESH: Sensitivity and Specificity Clinical trial Stenosis Angiography business Nuclear medicine MESH: Female [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology Magnetic Resonance Angiography |
| Zdroj: | Radiology Radiology, Radiological Society of North America, 2006, 238 (3), pp.827-40. ⟨10.1148/radiol.2383041769⟩ |
| ISSN: | 0033-8419 1527-1315 |
| Popis: | International audience; PURPOSE: To prospectively evaluate accuracy of gadolinium-enhanced three-dimensional (3D) magnetic resonance (MR) angiography with gadodiamide and gadopentetate dimeglumine (0.1 mmol/kg), with intraarterial DSA as reference standard, for imaging abdominal and iliac arterial stenoses. MATERIALS AND METHODS: The study was approved by all institutional review boards; informed consent was obtained from each subject before procedures. Two hundred forty-seven subjects were included; 240 received either contrast agent and were available for safety analysis; 222 were available for accuracy analysis. Enhanced 3D MR angiography and DSA were performed; image data were evaluated in a double-blinded randomized study. Stenoses were classified as not relevant ( or =50%). For detection of main stenosis, accuracy with enhanced 3D MR angiography compared with that with DSA was determined. RESULTS: The difference in accuracy for imaging with gadodiamide and gadopentetate was 3.6%. Noninferiority was inferred because the lower bound of the exact two-sided 95% confidence interval was -10.1 and was above the noninferiority margin (-15%). Accuracy for detection of the main stenosis was low, 56.4% for gadodiamide and 52.8% for gadopentetate group. Subgroup analysis with exclusion of inferior mesenteric artery and internal iliac arteries and the most false-positive stenosis classifications yielded better results: 76.6% and 71.6%, respectively. Sensitivity, specificity, and negative and positive predictive values did not differ substantially between study groups. In the main analysis, values were 44%, 96%, 35%, and 97% for gadodiamide and 44%, 83%, 30%, and 90% for gadopentetate, respectively. In the subgroup analysis, values were 66%, 95%, 61%, and 96% for gadodiamide and 63%, 86%, 58%, and 88% for gadopentetate, respectively. CONCLUSION: Noninferiority of gadodiamide versus gadopentetate was verified based on the primary end point, which was accuracy for detection of the main stenosis with enhanced 3D MR angiography compared with DSA. |
| Databáze: | OpenAIRE |
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