title: Detection of hepatocellular carcinoma and liver metastases with BR14: a multicenter phase IIA study.
abstract: The study was designed primarily to find the optimal dosage range of BR14 contrast-enhanced ultrasonography (CEUS) to detect malignant focal liver lesions. Secondary objectives were the evaluation of the safety profile and comparison with contrast-enhanced MRI (CE MRI). We studied 25 patients (9 females, 16 males, mean age, 66 years) with known hepatocellular carcinoma or liver metastases at 3 centers over a 3-month period. Each patient underwent a baseline examination and at least 3 CEUS examinations with ascending dose levels (0.25 mL; 1.0 mL; 4.0 mL) of BR14. CE MRI was performed 4 weeks before or after the CEUS examination. Dedicated liver maps were used to record the location, size, and type of detected lesions. Examination quality was documented and safety parameters were assessed. The number of lesions detected by BR14 CEUS increased with dosage, whereas the number of missed lesions and the lesion sizes decreased. Despite the increasing contrast enhancement, substantial differences among dosages were not seen for other image quality parameters. No significant changes were noted in safety parameters and no serious adverse events were reported. We conclude that the recommended dose level of BR14 is between 1 mL and 4 mL; at this dosage, lesion detection is comparable to that of CE MRI.
authors.affiliation: Department of Radiology and Nuclear Medicine, University Hospital Basel, University of Basel, Basel, Switzerland. jhohmann@uhbs.ch
authors.forename: Joachim
authors.initials: J
authors.lastname: Hohmann
authors.forename: Anja
authors.initials: A
authors.lastname: Müller
authors.forename: Jan
authors.initials: J
authors.lastname: Skrok
authors.forename: Karl-Jürgen
authors.initials: KJ
authors.lastname: Wolf
authors.forename: Alberto
authors.initials: A
authors.lastname: Martegani
authors.forename: Christoph F
authors.initials: CF
authors.lastname: Dietrich
authors.forename: Thomas
authors.initials: T
authors.lastname: Albrecht
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging* / Q000556:secondary*; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005466:Fluorocarbons / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008113:Liver Neoplasms / Q000000981:diagnostic imaging*; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014463:Ultrasonography
chemical_list: C471302:BR14 contrast agent; D003287:Contrast Media; D005466:Fluorocarbons; D010743:Phospholipids