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

• Sponsor: Kaohsiung Veterans General Hospital. (Other)
• Overall Status: Completed
• CT.gov ID: NCT05797129
• Collaborator: (none)
• Enrollment: 351
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 9.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: CEDM

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 351 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women underwent CEDM screening

Exclusion Criteria:

• incomplete imaging exams

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	813

Sponsors and Collaborators

• Kaohsiung Veterans General Hospital.

Investigators

• Principal Investigator: Chen-Pin Chou, MD, Kaohsiung Veterans General Hospital.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chen-Pin Chou, Radiologist, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT05797129
• Other Study ID Numbers: VGHKS18-CT11-17
• First Posted: Apr 4, 2023
• Last Update Posted: Apr 4, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chen-Pin Chou, Radiologist, Kaohsiung Veterans General Hospital.: breast cancer; Contrast-enhanced digital mammography
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 4, 2023