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.
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.
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.
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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Watanabe R, Matsumura M, Munemasa T, et al. Mechanism of hepatic parenchyma-specific contrast of microbubble-based contrast agent for ultrasonography. Invest Radiol. 2007;42:643–51.
Matsuda T, Marugame T, Kamo K, The Japan Cancer Surveillance Research Group, et al. Cancer incidence and incidence rates in Japan in 2002: based on data from 11 population-based cancer registries. Jpn J Clin Oncol. 2008;38(9):641–8.
Oono Y, Nakamura T, Murata K, et al. Future estimations of cancer prevalence in Japan. White paper on cancer statistics. Tokyo: Shinohara Press; 2004. p. 201–17.
Changes in the number of deaths caused by major malignant neoplasms (database on the Internet) 2007 Demographics (data from Ministry of Health, Labour and Welfare). http://www.mmjp.or.jp/kawakami-clinic/data/h19suii.htm. Updated 19 Sept 2008; cited 11 July 2011.
National Cancer Center (homepage on the Internet). Tokyo: Center for Cancer Control and Information Services (Cancer Information Service) Breast cancer. http://ganjoho.ncc.go.jp/professional/statistics/digest/digest12.html. Updated 1 Oct 2006; cited 11 July 2011.
National Cancer Center (homepage on the Internet). Tokyo: Center for Cancer Control and Information Services (Cancer Information Service) Cancer screening. http://ganjoho.jp/professional/pre_scr/screening/screening.html#03. Updated 5 Apr 2010; cited 11 July 2011.
de Gonzalez AB, Darby S. Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries. Lancet. 2004;363:345–51.
Du J, Li FH, Fang H, et al. Microvascular architecture of breast lesions: evaluation with contrast-enhanced ultrasonographic micro flow imaging. J Ultrasound Med. 2008;27:833–42.
Japanese Breast Cancer Society, editor. Breast cancer management guidelines. vol. 4. Screening and diagnosis. Kanehara Shuppan; 2008:18–19.
Sonazoid® for Injection (package insert). Daiichi Sankyo Co., Ltd. June 2011.
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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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
- Ultrasound contrast medium
- Breast tumors
- Phase II clinical study