Objective To evaluate the role of ^1H spetral selected point-resolved spectroscopy （SS-PRESS） sequence in distingnishing benign from malignant breast lesions by the malignancy marker of choline peak and to investiga...Objective To evaluate the role of ^1H spetral selected point-resolved spectroscopy （SS-PRESS） sequence in distingnishing benign from malignant breast lesions by the malignancy marker of choline peak and to investigate the factors influencing the diagnosis. Methods A total of 131 patients （ aged 24-83 years, average 44. 8 years） were enrolled in this study. The examinations were performed on a 1.5T scanner with four-channel phased array breast coiL Singie-voxel proton magnetic resonance spectroscopy （1H MRS） was acquired by SS-PRESS sequence in these patients referred to surgical or biopsy consultation. Results Among these patients, 74 were proved to have breast carcinomas and 57 have benign lesions by histopathological examinations, Thirty-one elevated choline peaks were observed in these 74 confirmed malignant lesions, and 5 detectable choline peaks were demonstrated in the 57 benign lesions. The sensitivity and specificity of ^1H SSPRESS MRS were 41.9% and 91.2%, respectively. The main factors influencing the diagnosis were signal-to-noise ratio and pathological type. Conclusions ^1H SS-PRESS MRS can provide a noninvasive, biochemical measurement of metabolism and improve the specificity of breast magnetic resonance imaging. Choline peak in vivo is a specific but not sensitive marker of malignancy. Technique factors and histopathological characterization of lesions influence the detection rate.展开更多
Spinal acrylic bone cements(ABCs)are used clinically for percutaneous vertebroplasty(PVP)and kyphoplasty(PKP)to treat osteoporotic vertebral compression fractures.Product translation of spinal ABC products followed th...Spinal acrylic bone cements(ABCs)are used clinically for percutaneous vertebroplasty(PVP)and kyphoplasty(PKP)to treat osteoporotic vertebral compression fractures.Product translation of spinal ABC products followed the design control processes including design verification and validation.The bench to bedside translation of the first Chinese spinal ABC product(Alliment®,namely Alliment Cement)approved by National Medical Products Administration of China was investigated and another commercial product served as the control(Osteopal®V,namely Osteopal V Cement).Results of non-clinical bench performance verification tests of compression,bending and monomer release showed that the newly marketed Alliment Cement is similar to the Osteopal V Cement with properties of both meeting the criteria specified by standards.The Alliment Cement demonstrated good biocompatibility during the 26 weeks’bone implantation test.Porcine cadaver validation tests further revealed that the Alliment Cement satisfied the needs for both PVP and PKP procedures.A post-approval,retrospective clinical investigation further demonstrated the safety and efficacy of the Alliment Cement,with a significant reduction of pain and the improved stability of the fractured vertebral bodies.A successful translation of biomaterial medical products needs close collaborations among academia,industry,healthcare professionals and regulatory agencies.展开更多
文摘Objective To evaluate the role of ^1H spetral selected point-resolved spectroscopy （SS-PRESS） sequence in distingnishing benign from malignant breast lesions by the malignancy marker of choline peak and to investigate the factors influencing the diagnosis. Methods A total of 131 patients （ aged 24-83 years, average 44. 8 years） were enrolled in this study. The examinations were performed on a 1.5T scanner with four-channel phased array breast coiL Singie-voxel proton magnetic resonance spectroscopy （1H MRS） was acquired by SS-PRESS sequence in these patients referred to surgical or biopsy consultation. Results Among these patients, 74 were proved to have breast carcinomas and 57 have benign lesions by histopathological examinations, Thirty-one elevated choline peaks were observed in these 74 confirmed malignant lesions, and 5 detectable choline peaks were demonstrated in the 57 benign lesions. The sensitivity and specificity of ^1H SSPRESS MRS were 41.9% and 91.2%, respectively. The main factors influencing the diagnosis were signal-to-noise ratio and pathological type. Conclusions ^1H SS-PRESS MRS can provide a noninvasive, biochemical measurement of metabolism and improve the specificity of breast magnetic resonance imaging. Choline peak in vivo is a specific but not sensitive marker of malignancy. Technique factors and histopathological characterization of lesions influence the detection rate.
文摘Spinal acrylic bone cements(ABCs)are used clinically for percutaneous vertebroplasty(PVP)and kyphoplasty(PKP)to treat osteoporotic vertebral compression fractures.Product translation of spinal ABC products followed the design control processes including design verification and validation.The bench to bedside translation of the first Chinese spinal ABC product(Alliment®,namely Alliment Cement)approved by National Medical Products Administration of China was investigated and another commercial product served as the control(Osteopal®V,namely Osteopal V Cement).Results of non-clinical bench performance verification tests of compression,bending and monomer release showed that the newly marketed Alliment Cement is similar to the Osteopal V Cement with properties of both meeting the criteria specified by standards.The Alliment Cement demonstrated good biocompatibility during the 26 weeks’bone implantation test.Porcine cadaver validation tests further revealed that the Alliment Cement satisfied the needs for both PVP and PKP procedures.A post-approval,retrospective clinical investigation further demonstrated the safety and efficacy of the Alliment Cement,with a significant reduction of pain and the improved stability of the fractured vertebral bodies.A successful translation of biomaterial medical products needs close collaborations among academia,industry,healthcare professionals and regulatory agencies.
