Efficacy of perflubutane microbubble-enhanced ultrasound in the characterization and detection of focal liver lesions: Phase 3 multicenter clinical trial

American Journal of Roentgenology

Volumn 193, Issue 1, 2009, Pages 86-95

  Moriyasu, Fuminori ^a   Itoh, Kouichi ^b,c  

^a TOKYO MEDICAL UNIVERSITY   (Japan)

^b JICHI MEDICAL UNIVERSITY   (Japan)

^c Hitachi Omiya Saiseikai Hospital   (Japan)

Author keywords

Characterization; Contrast enhanced ultrasound; Detection; Focal liver lesions; Perflubutane

Indexed keywords

PERFLUBUTANE; DIAGNOSTIC AGENT; FLUOROCARBON;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ALBUMINURIA; ARTICLE; B SCAN; BLOOD PRESSURE; CLINICAL PRACTICE; CLINICAL TRIAL; COLOR ULTRASOUND FLOWMETRY; COMPUTER ASSISTED TOMOGRAPHY; CONTRAST ENHANCEMENT; DIAGNOSTIC ACCURACY; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; EPIGASTRIC PAIN; FEMALE; FEVER; FLANK PAIN; GLUCOSURIA; HEADACHE; HOT FLUSH; HUMAN; HYPERTENSION; INJECTION SITE PAIN; JAPAN; KUPFFER CELL; LACTATE DEHYDROGENASE BLOOD LEVEL; LIVER CELL CARCINOMA; LIVER HEMANGIOMA; LIVER INJURY; LIVER METASTASIS; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MICROBUBBLE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OMALGIA; PAIN; PERIPHERAL ISCHEMIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; STUPOR; THIRST; THROMBOCYTOPENIA; ULTRASOUND; VOMITING; ECHOGRAPHY; IMAGE ENHANCEMENT; LIVER TUMOR; METHODOLOGY; MIDDLE AGED; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; FLUOROCARBONS; HUMANS; IMAGE ENHANCEMENT; LIVER NEOPLASMS; MALE; MICROBUBBLES; MIDDLE AGED; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 67650303096     PISSN: 0361803X     EISSN: None     Source Type: Journal    
DOI: 10.2214/AJR.08.1618     Document Type: Article

References (35)

1. Goldberg BB, Liu JB, Forsberg F. Ultrasound contrast agents: a review. Ultrasound Med Biol 1994; 20:319-333
2. Cosgrove D. Echo enhancers and ultrasound imaging. Eur J Radiol 1997; 26:64-76
3. Chomas JE, Dayton P, Allen J, Morgan K, Ferrara KW. Mechanisms of contrast agent destruction. IEEE Trans Ultrason Ferroelectr Freq Control 2001; 48:232-248
4. Kim TK, Han JK, Kim AY, Choi BI. Limitations of characterization of hepatic hemangiomas using a sonographic contrast agent (Levovist) and power Doppler ultrasonography. J Ultrasound Med 1999; 18:737-743 (Pubitemid 29504026)
5. Klibanov AL, Ferrara KW, Hughes MS, et al. Direct video-microscopic observation of the dynamic effects of medical ultrasound on ultrasound contrast microspheres. Invest Radiol 1998; 33:863-870 (Pubitemid 30247058)
6. Schutt EG, Klein DH, Mattrey RM, Riess JG. Injectable microbubbles as contrast agents for diagnostic ultrasound imaging: the key role of perfluorochemicals. Angew Chem Int Ed Engl 2003; 42:3218-3235 (Pubitemid 36917164)
7. Lindner JR. Microbubbles in medical imaging: current applications and future directions. Nat Rev Drug Discov 2004; 3:527-532 (Pubitemid 38807535)
8. de Jong N, Frinking PJ, Bouakaz A, Ten Cate FJ. Detection procedures of ultrasound contrast agents. Ultrasonics 2000; 38:87-92 (Pubitemid 30592603)
9. Metoki R, Moriyasu F, Kamiyama N, et al. Quantification of hepatic parenchymal blood flow by contrast ultrasonography with flash-replenishment imaging. Ultrasound Med Biol 2006; 32:1459-1466 (Pubitemid 44528109)
10. Burns PN, Wilson SR, Simpson DH. Pulse inversion imaging of liver blood flow: improved method for characterizing focal masses with microbubble contrast. Invest Radiol 2000; 35:58-71 (Pubitemid 30033608)
11. Brannigan M, Burns PN, Wilson SR. Blood flow patterns in focal liver lesions at microbubble-enhanced US. RadioGraphics 2004; 24:921-935 (Pubitemid 38943326)
12. Leen E, Ceccotti P, Kalogeropoulou C, Angerson WJ, Moug SJ, Horgan PG. Prospective multicenter trial evaluating a novel method of characterizing focal liver lesions using contrast-enhanced sonography. AJR 2006; 186:1551-1559 (Pubitemid 46112517)
13. Nicolau C, Vilana R, Catalá V, et al. Importance of evaluating all vascular phases on contrast-enhanced sonography in the differentiation of benign from malignant focal liver lesions. AJR 2006; 186:158-167 (Pubitemid 46100378)
14. Sontum PC. Physicochemical characteristics of Sonazoid, a new contrast agent for ultrasound imaging. Ultrasound Med Biol 2008; 34:824-833 (Pubitemid 351608046)
15. Watanabe R, Matsumura M, Chen CJ, Kaneda Y, Ishihara M, Fujimaki M. Gray-scale liver enhancement with Sonazoid (NC100100), a novel ultrasound contrast agent: detection of hepatic tumors in a rabbit model. Biol Pharm Bull 2003; 26:1272-1277 (Pubitemid 41656561)
16. Yanagisawa K, Moriyasu F, Miyahara T, Miyata Y, Iijima H. Phagocytosis of ultrasound contrast agent microbubbles by Kupffer cells. Ultrasound Med Biol 2007; 33:318-325 (Pubitemid 46240604)
17. Watanabe R, Matsumura M, Munemasa T, Fujimaki M, Suematsu M. Mechanism of hepatic parenchyma-specific contrast of microbubble-based contrast agent for ultrasonography: microscopic studies in rat liver. Invest Radiol 2007; 42:643-651 (Pubitemid 47262933)
18. Kindberg GM, Tolleshaug H, Roos N, Skotland T. Hepatic clearance of Sonazoid perfluorobutane microbubbles by Kupffer cells does not reduce the ability of liver to phagocytose or degrade albumin microspheres. Cell Tissue Res 2003; 312:49-54 (Pubitemid 36578845)
19. Forsberg F, Piccoli CW, Liu JB, et al. Hepatic tumor detection: MR imaging and conventional US versus pulse-inversion harmonic US of NC100100 during its reticuloendothelial system-specific phase. Radiology 2002; 222:824-829 (Pubitemid 34215236)
20. Winterer JT, Kotter E, Ghanem N, Langer M. Detection and characterization of benign focal liver lesions with multislice CT. Eur Radiol 2006; 16:2427-2443 (Pubitemid 44649692)
21. Rettenbacher T. Focal liver lesions: role of contrast-enhanced ultrasound. Eur J Radiol 2007; 64:173-182 (Pubitemid 47588758)
22. Konopke R, Bunk A, Kersting S. The role of contrast-enhanced ultrasound for focal liver lesion detection: an overview. Ultrasound Med Biol 2007; 33:1515-1526 (Pubitemid 47444480)
23. Quaia E, Calliada F, Bertolotto M, et al. Characterization of focal liver lesions with contrast-specific US modes and a sulfur hexafluoride-filled microbubble contrast agent: diagnostic performance and confidence. Radiology 2004; 232:420-430 (Pubitemid 38971282)
24. Albrecht T, Blomley MJ, Burns PN, et al. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology 2003; 227:361-370 (Pubitemid 36514748)
25. Harvey CJ, Blomley MJ, Eckersley RJ, Heckemann RA, Butler-Barnes J, Cosgrove DO. Pulse-inversion mode imaging of liver specific microbubbles: improved detection of subcentimetre metastases. Lancet 2000; 355:807-808 (Pubitemid 30128824)
26. Blomley MJ, Albrecht T, Cosgrove DO, et al. Improved imaging of liver metastases with stimulated acoustic emission in the late phase of enhancement with the US contrast agent SH U 508A: early experience. Radiology 1999; 210:409-416 (Pubitemid 29055309)
27. Reimer P, Balzer T. Ferucarbotran (Resovist): a new clinically approved RES-specific contrast agent for contrast-enhanced MRI of the liver-properties, clinical development, and applications. Eur Radiol 2003; 13:1266-1276 (Pubitemid 36790627)
28. Tanimoto A, Kuribayashi S. Application of super-paramagnetic iron oxide to imaging of hepatocellular carcinoma. Eur J Radiol 2006; 58:200-216
29. Parikh S, Hyman D. Hepatocellular cancer: a guide for the internist. Am J Med 2007; 120:194-202
30. Okita K. Clinical aspects of hepatocellular carcinoma in Japan. Intern Med 2006; 45:229-233
31. Kobayashi K, Terasaki S, Matsushita E, Kaneko S. Strategy of early diagnosis. Kan-Tan-Sui Frontier 1999; 5:57-59
32. Bruix J, Sherman M. Diagnosis of small HCC. Gastroenterology 2005; 129:1364
33. Berrington de González A, Darby S. Risk of cancer from diagnostic x-rays: estimates for the UK and 14 other countries. Lancet 2004; 363:345-351 (Pubitemid 38169539)
34. Bluemke DA, Sahani D, Amendola M, et al. Efficacy and safety of MR imaging with liver-specific contrast agent: U.S. multicenter phase III study. Radiology 2005; 237:89-98 (Pubitemid 41346150)
35. Haider MA, Amitai MM, Rappaport DC, et al. Multi-detector row helical CT in preoperative assessment of small (< or = 1.5 cm) liver metastases: is thinner collimation better? Radiology 2002; 225:137-142