ew frontiers in breast imaging: contrast enhanced digital mammography. - Clinical performance of contrast-enhanced spectral mammography (CESM - SenoBright?) in pre-surgical evaluation of extent of malignancy in a population of women with breast cancer.

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2012年3月8日最近更新: 2012年4月24日

适应症

试验速览

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•1. Woman diagnosed with breast cancer from FFDM and/or US imaging and for whom a pre-surgical evaluation of extent of disease (including multi-focality) is recommended 2. The subject has dense breasts (BIRADS class 3 or 4 on FFDM) 3. Capable and willing to comply with study procedures, and having signed and dated the informed consent form 4. The subject must have a breast size compatible with the dimensions of the image detector 5. The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 132
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 46

•1. The subject is known to have risks of adverse effects with iodine contrast agents. 2. The subject is asymptomatic and without suspicious findings from routine imaging. 3. The subject has BI-RADS 1, 2 breast density class evaluation from latest mammography. 4. The subject has been previously included in this study. 5. The subject has breasts too large to be adequately positioned on FFDM digital receptor without anatomical cut off during an FFDM examination. 6. The subject is participating in, or has participated (within the prior 30 days) in another clinical trial whit drugs. 7. Has breast implant(s). 8. Has reconstructed breast(s). 9. The subject underwent a prior radiotherapy treatment. 10. The subject is undergoing radiotherapy in the thorax area or chemotherapy. 11. The subject is in such a bad health that she is not able to undergo study examinations. 12. Proved or supposed pregnancy.

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