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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast enhanced mammography vs standard digital mammogram | Experimental | Contrast-enhanced spectral mammography for the detection breast cancer . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-Energy Contrast-Enhanced (DECE) mammography | Device | Contrast mammography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Call Backs With Contrast Mammography | •The patients identified for additional imaging based on unconfirmed findings. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi R Umphrey, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contrast Enhanced Mammography vs Standard Digital Mammograpm | Contrast-enhanced spectral mammography for the detection breast cancer . Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
114 patients completed both mammograms
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| ID | Title | Description |
|---|---|---|
| BG000 | Contrast Enhanced Mammography vs Standard Digital Mammograpm | Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Consented 128 patients, 114 patients completed both mammograms | Posted | Number | 95% Confidence Interval | percentage of accuracy | 1 year |
|
Adverse events will be recorded on the CRFs up to 30 days after administration of the last dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contrast Enhanced Mammography vs Standard Digital Mammograpm | Contrast-enhanced spectral mammography for the detection breast cancer . DECE mammography: Contrast mammography |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Lancaster, MD | University of Alabama at Birmingahm | 205-934-4080 | mvetrano@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 13, 2018 | Jun 26, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| digital mammography | Device | routine digital mammography |
|
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Full field digital mammography for the detection breast cancer
digital mammography: routine digital mammography
|
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| 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). | Consented 128 patients, 114 patients completed both mammograms | Posted | Count of Participants | Participants | 1 year |
|
|
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| Secondary | Number of Call Backs With Contrast Mammography | •The patients identified for additional imaging based on unconfirmed findings. | Consented 128 patients, 114 patients completed both mammograms | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
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| 0 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
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| D017437 |
| Skin and Connective Tissue Diseases |