NCT05797129

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

March 8, 2023

Last Update Submit

March 21, 2023

Conditions

Breast Cancer

Keywords

breast cancerContrast-enhanced digital mammography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Up to 3 years

  • True positive results obtained by the diagnostic method (Number)

    Up to 3 years

  • True negative results obtained by the diagnostic method (Number)

    Up to 3 years

Interventions

CEDMDEVICE

Women underwent CEDM screening

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women underwent CEDM screening at Kaohsiung Veterans General Hospital from January 2019 to December 2021

You may qualify if:

  • women underwent CEDM screening

You may not qualify if:

  • incomplete imaging exams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chen-Pin Chou, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 4, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.

Locations

TW(1)