Comparison of the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CESM) and conventional imaging of Breast Carcinoma.
- Conditions
- Participants in this study will be adult female who fulfills the following four criteria: 1. Examined by mammography or ultrasound this past year, and was diagnosed as ACR category 3. 2. Diagnosed as CESM applicant by research investigator or sub investigator, having interview, clinical breast examination, and other examinations. 3. Adult female over 20 years old 4. Signed a consent form to participate this clinical study
- Registration Number
- JPRN-UMIN000004912
- Lead Sponsor
- CESM society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Not provided
Exclude patients who meet the following criteria 1 Complications and/or preexisting disorders of respiratory disease, such as asthma,chronic obstructive pulmonary disease, pulmonary cancer, and interstitial pneumonia. 2 Preexisting disorders of being allergic to iodinated contrast material and iodine-containing drug medicine, complications and/or preexisiting disorders of allergists, such as drug allegy and alimentary allergy. 3 Complications and/or preexisting disorders of the thyroid gland 4 Diabetes drug (metformin) and is not able to take sufficient drug holidays brfore and affer the study (Over 48 hours for bot before and after the study) 5 Patient whose general condition is significantly disordered or has complocations and/or preexisiting disorders of critical cerebropathy, such as hematencephalon and stroke, liver disease, such as hepatic cirrhosis and hpatic failure, kidney disease, such as glomerulonephritis and patient who requiring dialysis. 6 Complications of acute pancreatitis, Waldenstorm's macroglobulinemia multiple myeloma, tetany, and pheochromocytoma. 7 Patinet who performed breast enlargement sturgery including saline-filled and silicone-gel-filled implants. 8 Patient who is diagnosed as mental disorders including moderate or severe dementia and identified by attending physician that she neither fully comprehend nor cooperate. 9 Pregnant women or breast-feeding women. 10.Who is participating or has participanter clinical research study and/or past marketing surveillance for last three months period. 11 Others;attending physician has cancers for a patient to join this clinical study and/or for a patient to be a hinder of evaluation the result. Reasons of creating exclusion criteria are as follows 1,2,3,4,5,6; contraindicated disease of iodinated contrast materials 7;affecting the risk for interpretation of radiogram 8,9,10,11;general considerations of clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Primary Endpoint Evaluate the sensitivity of CESM 2. Secondary endpoint Evaluate characteristics and adverse events of CESM
- Secondary Outcome Measures
Name Time Method