B-0232 Detection of HCC and liver metastases with BR14: final results of a multicentre phase IIA study

J. Hohmann, A. Müller, J. Skrok, K.-J. Wolf, A. Martegani, C.F. Dietrich, T. Albrecht | Thursday, March 7, 14:00 – 15:30 / Room I/K

Purpose: The study was primarily designed to find the optimal dose range of BR14 to detect malignant focal liver lesions. Secondary objectives were the evaluation of the safety profile and comparison with contrast-enhanced MRI (CE MRI).
Methods and Materials: 25 patients (9f, 16m, mean age: 66y) with known HCC or liver metastases were examined in three centres during a time period of three months. Each patient underwent a baseline and at least three contrast-enhanced US (CEUS) with ascending dose levels (0.25ml, 1.0ml, 4.0ml) of BR14. CE MRI was done 4 weeks prior or post-study examination. Lesions were recorded in on a liver map, with respect to localisation, size and suggested lesion type. Examination quality was documented and safety parameters were assessed.
Results: The number of lesions detected with BR14 CEUS increased with dose, while the number of missed lesions and the lesion size decreased. Despite the increasing contrast enhancement no other image quality parameter showed a substantial difference. No significant changes were found for the analysed safety parameters and no serious adverse events were reported.
Conclusion: We finally conclude that the recommended dose level of BR14 is between 1.0 ml and 4.0 ml for which the lesion detection was comparable to the CE MRI. In addition, we found a higher number of especially small lesions with higher doses of BR14 which might be due to a higher sensitivity of CEUS for the detection of liver metastases. However, this is an interesting and debatable finding.

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