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CIST Pilot Study
Spectral mammography for lesion characterization: A pilot study (Characterization using Imaging with Spectral mammography of Tissue)
Breast cancer is the most common cause of death for European women between 20 and 70 years of age, with approximately 430,000 new breast cancer diagnoses every year. Over 20 million European women are screened annually for early detection through mammography. Screening with x-ray mammography has been shown to reduce mortality in a number of well-conducted randomised controlled trials. But the sensitivity of this technique is far from perfect, with up to a third of the cancers in the UK screening population, aged 47 to 70 years, presenting between screens Sensitivity is even lower in younger women who have a relative preponderance of glandular tissue.
Our proposed pilot study on spectral mammography for lesion characterization aims at evaluating and refining the recently developed lesion characterization tool, and to determine if the results from the tissue study can be translated into clinical practice. This is to be an open, non-randomised study. The primary objective is to collect real-time spectral imaging data in a pilot study to determine the feasibility of assessing the water contents in lesions and to determine whether the difference in attenuation can be used to characterize round lesions as cystic or solid on mammographic spectral imaging. The primary endpoint is to assess the sensitivity and specificity of the spectral imaging data acquired from the Philips MicroDose system in distinguishing cystic from solid benign and malignant lesions on mammography.
A total of approximately 600 patients will be recruited who are having mammograms as part of their routine clinical assessment. The patients will continue to receive their usual assessment with no change in standard care. No additional visits will be required for this study. This study will not affect the timing of their treatment/diagnosis as images will be anonymised and processed off-line after the patient’s diagnosis has been confirmed on ultrasound/ pathology. It is estimated it will take approximately 6 months to recruit 600 patients.
Main inclusion criteria
Women aged 35 and over undergoing mammograms as part of their routine diagnostic evaluation.
Participant is willing and able to give informed consent for participation in the study.
Main exclusion criteria
The participant may not enter the study if ANY of the following apply:
Any woman unable to give informed consent, including those who are unable to understand the nature and purpose of the study
Any woman who is being followed-up for a non-breast cancer diagnosis.
Any woman with a history of treated breast cancer.
Funders and sponsors
Dr Matthew Wallis
Clinical Trials Manager: Dr Paula Kareclas
Telephone: 01223 596473 | Email: [email protected]