Comparison of the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CESM) and conventional imaging of Breast Carcinoma. - Evaluation of Contrast Enhanced Spectral Mammography

CESM society0 sites60 target enrollmentJanuary 22, 2011

ConditionsParticipants 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

Overview

Phase: 未知
Intervention: Not specified
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
Sponsor: CESM society
Enrollment: 60
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2011

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

CESM society

Eligibility Criteria

Inclusion Criteria

Not provided

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