CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study

Study Overview
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Brief Summary
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To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.

Detailed Description
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The aim of this study was to evaluate the effectiveness of different imaging techniques for detecting breast cancer in women with a higher risk due to personal or family history of the disease.

Official Title
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CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: CEDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women underwent CEDM screening Exclusion Criteria: incomplete imaging exams

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CEDM|Women underwent CEDM screening|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of cases received and diagnosed with breast cancer (Number) | This refers to the total number of individuals who underwent breast cancer screening or assessment and the number diagnosed with breast cancer. Evaluating the accuracy of screening tests using measures such as true positives and true negatives is crucial for assessing the reliability of screening tests and identifying potential issues. These measures help healthcare professionals make informed decisions about screening and diagnostic strategies. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number) | This refers to the total number of individuals who underwent breast cancer screening or assessment and tested positive, requiring a biopsy and MRI for further evaluation. A biopsy is necessary to confirm whether an individual has breast cancer. Monitoring the diagnostic accuracy of breast cancer screening tests and the number of individuals requiring further procedures is essential for determining appropriate treatment or monitoring. Measures such as true positives and true negatives are used to evaluate the accuracy of screening tests. | Up to 3 years | 
| True positive results obtained by the diagnostic method (Number) | The total number of true positive results obtained by the diagnostic method, indicating the cases with breast cancer that are correctly identified. A higher number of true positives demonstrates better performance in correctly identifying cases with breast cancer. | Up to 3 years | 
| True negative results obtained by the diagnostic method (Number) | The total number of true negative results obtained by the diagnostic method, indicating the cases without breast cancer that are correctly identified. A higher number of true negatives demonstrates better performance in correctly identifying cases without breast cancer and reducing false positives. | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, Contrast-enhanced digital mammography