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OpenTrials
Completed

NCT Number: NCT05797129

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women underwent CEDM screening

Exclusion criteria

  • incomplete imaging exams

Treatment and study plan

CEDM

Device

Women underwent CEDM screening

Primary outcomes

  1. Total number of cases received and diagnosed with breast cancer (Number)

    Time frame: Up to 3 years

    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.

Secondary outcomes

  1. Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)

    Time frame: Up to 3 years

    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.

  2. True positive results obtained by the diagnostic method (Number)

    Time frame: Up to 3 years

    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.

  3. True negative results obtained by the diagnostic method (Number)

    Time frame: Up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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