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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02995980
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arm: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Dual-Energy Contrast-Enhanced (DECE) mammography; Device: digital mammography	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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)
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contrast enhanced mammography vs standard digital mammogram Contrast-enhanced spectral mammography for the detection breast cancer .	Device: Dual-Energy Contrast-Enhanced (DECE) mammography; Contrast mammography; Other Names: Contrast-enhanced spectral mammography (CESM) Contrast-enhanced mammography ; Device: digital mammography; routine digital mammography; Other Names: full field digital mammography

Outcome Measures

Primary Outcome Measures

1. Percent Accuracy of Contrast Mammography [1 year]

   •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).

2. Number of Participants With Cancer Detected [1 year]

   •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).

Secondary Outcome Measures

1. Number of Call Backs With Contrast Mammography [1 year]

   •The patients identified for additional imaging based on unconfirmed findings.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Kirklin Clinic	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Heidi R Umphrey, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 13, 2018

More Information

Publications

None provided.

• Responsible Party: Rachael Lancaster, MD, MD, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02995980
• Other Study ID Numbers: F141210004
• First Posted: Dec 19, 2016
• Last Update Posted: Sep 25, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rachael Lancaster, MD, MD, University of Alabama at Birmingham: breast cancer screening; dense breasts; dual-energy contrast-enhanced digital mammography
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Contrast Enhanced Mammography vs Standard Digital Mammograpm
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography
Period Title: Overall Study
STARTED	128
COMPLETED	114
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Contrast Enhanced Mammography vs Standard Digital Mammograpm
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography
Overall Participants	128
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	100 78.1%
>=65 years	28 21.9%
Sex: Female, Male (Count of Participants)
Female	128 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	100 78.1%
Not Hispanic or Latino	26 20.3%
Unknown or Not Reported	2 1.6%

Outcome Measures

1. Primary Outcome

Title	Percent Accuracy of Contrast Mammography
Description	•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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Consented 128 patients, 114 patients completed both mammograms

Arm/Group Title	Contrast Enhanced Mammography	Standard Digital Mammogram
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Measure Participants	114	114
Number (95% Confidence Interval) [percentage of accuracy]	100	67

2. Primary Outcome

Title	Number of Participants With Cancer Detected
Description	•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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Consented 128 patients, 114 patients completed both mammograms

Arm/Group Title	Contrast Enhanced Mammography	Standard Digital Mammogram
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Measure Participants	114	114
Count of Participants [Participants]	3 2.3%	2 NaN

3. Secondary Outcome

Title	Number of Call Backs With Contrast Mammography
Description	•The patients identified for additional imaging based on unconfirmed findings.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Consented 128 patients, 114 patients completed both mammograms

Arm/Group Title	Contrast Enhanced Mammography	Standard Digital Mammogram
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography	Full field digital mammography for the detection breast cancer digital mammography: routine digital mammography
Measure Participants	114	114
Number (95% Confidence Interval) [percentage of participants]	10 7.8%	11 NaN

Adverse Events

Time Frame	Adverse events will be recorded on the CRFs up to 30 days after administration of the last dose of study treatment.
Arm/Group Title	Contrast Enhanced Mammography vs Standard Digital Mammograpm
Arm/Group Description	Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography
All Cause Mortality
	Contrast Enhanced Mammography vs Standard Digital Mammograpm
	Affected / at Risk (%)	# Events
Total	0/128 (0%)
Serious Adverse Events
	Contrast Enhanced Mammography vs Standard Digital Mammograpm
	Affected / at Risk (%)	# Events
Total	0/128 (0%)
Other (Not Including Serious) Adverse Events
	Contrast Enhanced Mammography vs Standard Digital Mammograpm
	Affected / at Risk (%)	# Events
Total	0/128 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.