Breast Cancer
Conditions
Keywords
breast cancer screening, dense breasts, dual-energy contrast-enhanced digital mammography
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.
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
Interventions
DEVICEDual-Energy Contrast-Enhanced (DECE) mammography
Contrast mammography
DEVICEdigital mammography
routine digital mammography
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Call Backs With Contrast Mammography | 1 year | •The patients identified for additional imaging based on unconfirmed findings. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contrast Enhanced Mammography vs Standard Digital Mammograpm Contrast-enhanced spectral mammography for the detection breast cancer .
DECE mammography: Contrast mammography | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
Baseline characteristics
| Characteristic | Contrast Enhanced Mammography vs Standard Digital Mammograpm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
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).
Time frame: 1 year
Population: Consented 128 patients, 114 patients completed both mammograms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contrast Enhanced Mammography | Number of Participants With Cancer Detected | 3 Participants |
| Standard Digital Mammogram | Number of Participants With Cancer Detected | 2 Participants |
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).
Time frame: 1 year
Population: Consented 128 patients, 114 patients completed both mammograms
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Mammography | Percent Accuracy of Contrast Mammography | 100 percentage of accuracy |
| Standard Digital Mammogram | Percent Accuracy of Contrast Mammography | 67 percentage of accuracy |
Secondary
Number of Call Backs With Contrast Mammography
•The patients identified for additional imaging based on unconfirmed findings.
Time frame: 1 year
Population: Consented 128 patients, 114 patients completed both mammograms
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Mammography | Number of Call Backs With Contrast Mammography | 10 percentage of participants |
| Standard Digital Mammogram | Number of Call Backs With Contrast Mammography | 11 percentage of participants |