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Phase II clinical study of DD-723 (perflubutane): dose–response study in patients with breast tumors

Abstract

Purpose

We compared the contrast effect of three doses of DD-723 in subjects with breast tumors to determine the recommended dose. We then evaluated differential diagnosis results using plain ultrasonography, contrast-enhanced ultrasonography (plain + enhanced), and contrast-enhanced magnetic resonance imaging (MRI) compared to the pathological diagnosis.

Methods

To evaluate the contrast effect, contrast-enhanced ultrasonic images were independently evaluated in a randomized sequence by three blinded reviewers trained in the evaluation method beforehand. Multiple evaluation results from the three reviewers were used to assess the overall contrast effect. The differential diagnosis was evaluated independently by three blinded reviewers using contrast-enhanced ultrasonic images and contrast-enhanced magnetic resonance images in a randomized sequence; reviewers were also blinded to subject characteristics. Multiple evaluation results from the three reviewers were used to assess the overall differential diagnosis.

Results

The recommended dose of DD-723 is an intermediate dose of 0.12 μL MB/kg. Accuracy, sensitivity, and specificity were improved more in the differential diagnosis by contrast-enhanced ultrasonography than in plain ultrasonography. Accuracy and specificity were better and sensitivity similar compared to contrast-enhanced MRI.

Conclusions

An intermediate dose showed the highest efficacy in terms of overall contrast effect. Contrast-enhanced ultrasonography is safe and useful when used in differential diagnosis.

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Acknowledgments

We thank Professor Fuminori Moriyasu (Tokyo Medical University) for useful suggestions and Satoshi Tatsuno (Tokyo Dental College Ichikawa General Hospital), Masanori Nagase (Tokyo Rosai Hospital), and Takako Shirakawa (JR Tokyo General Hospital) for MRI evaluation.

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Correspondence to Yukio Miyamoto.

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Miyamoto, Y., Ito, T., Takada, E. et al. Phase II clinical study of DD-723 (perflubutane): dose–response study in patients with breast tumors. J Med Ultrasonics 39, 79–86 (2012). https://doi.org/10.1007/s10396-011-0342-7

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Keywords

  • Ultrasound contrast medium
  • Breast tumors
  • Phase II clinical study
  • Sonazoid