Efficacy of contrast enhanced spectral mammography versus standard of care imaging tests (tomosynthesis and ultrasound) in women with mammographically dense breast tissue recalled for investigation of abnormalities detected on routine screening mammograms.

Royal Perth Hospital0 个研究点目标入组 69 人开始时间: 2016年4月26日最近更新: 2020年3月10日

适应症

试验速览

暂无简介。

•1. Written informed consent
•2. Women between the ages of 18 and 65 years with dense breast tissue on their mammograms who have been recalled for further assessment of a non calcified lesion detected on screening mammography
•3. Women with one or more non-calcified lesions detected on mammography where tomosynthesis is indicated as part of the assessment investigations.
•4. Presence of dense breasts (heterogeneously or extremely dense background parenchymal pattern) on mammography

•1. Lesions for which a standard work-up procedure would not include Tomosynthesis
•2. Presence of breast prostheses (CESM does not give good images in presence of prostheses)
•3. Poor mobility (Participants must be able to stand and be positioned adequately)
•4. Pregnancy or lactation
•5. Previous reaction to IV iodinated or gadolinium contrast
•6. History of multiple allergies requiring medical treatment
•7. History of asthma
•8. Women unable to give informed consent due to intellectual impairment
•9. Women whose primary language is not English whose level of comprehension is believed to be insufficient for them to be able to give written informed consent without a Health Department approved interpreter
•10. Poor mobility / physical limitations that would make CESM study impractical to perform
•11. Presence of risk factors for or a known history of impaired renal function (as identified using the IV contrast administration guidelines)
•12. Age over 65
•13. Diabetic
•14. Thyroid disease: Untreated hyperthyroidism or presence of a known hyperfunctioning thyroid nodule. Patients scheduled to undergo diagnostic or therapeutic procedures involving radioisotope scanning of the thyroid (including thyroid cancer treatment) (radioisotope uptake will be prevented for 8 weeks following iodinated contrast administration).
•15. History of Myasthenia Gravis
•16. Women who are taking Beta Blocking medication
•17. Women who are being treated with Interleukin-2

发起方