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
Conditions
Interventions
30 cases for both group A Duration of study: January 2011 to June 30 Contrast agent: Nonionic solution containing 350 mg of iodine per milliliter X-ray: radiology exposure less than 0.2mSv
Sponsors
CESM society
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Objective of participant selection is to satisfy following selection criteria and not conflict with exclusion criteria. Criteria for selecting participants: Adult female who visit research laboratories to be diagnosed breast cancer using diagnostic imaging, and fulfill following criteria; 1.Conducted PM and/or US this past year and diagnosed as ACR category 3 2.Diagnosed as CESM applicant by research investigator or sub investigator's interview, clinical breast examination, and other examinations. 3.Adult female over 20 years old. Signed a consent form to participate this clinical study
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Primary Endpoint Evaluate the sensitivity of CESM 2. Secondary endpoint Evaluate characteristics and adverse events of CESM | — |
Countries
Japan
Outcome results
None listed