Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography

Breast Cancer Clinical Trial

Official title:

Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995980
• Other study ID #: F141210004
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

Description:

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent

2. At least 19 years old

3. Glomerular filtration rate> 60

4. Heterogeneously or extremely dense breasts (BI-RADS category c or d).

Exclusion Criteria:

1. History of iodinated contrast allergy

2. Pregnant or lactating as determined by routine standard practice

3. Personal history of breast cancer

4. History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)

5. History of prior breast reduction mammoplasty surgery

6. History of prior breast augmentation surgery

7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Dual-Energy Contrast-Enhanced (DECE) mammography
Contrast mammography
• digital mammography
routine digital mammography

Locations

Country	Name	City	State
United States	The Kirklin Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Accuracy of Contrast Mammography	•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).	1 year
Primary	Number of Participants With Cancer Detected	•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).	1 year
Secondary	Number of Call Backs With Contrast Mammography	•The patients identified for additional imaging based on unconfirmed findings.	1 year