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| Name | Class |
|---|---|
| Duke Health | OTHER |
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A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.
Prospective, single-arm, non-blinded, comparative/observational study.
Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.
Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.
Phase 3: Test the performance of the monochromatic system using reduced breast compression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test device vs standard of care | Experimental | Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-D Monochromatic X-ray Mammography System | Device | Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography | Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. [Likert scale 1-3. Higher score is a better outcome] | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) |
| Measure | Description | Time Frame |
|---|---|---|
| Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography | Assess ability of monochromatic-based X-ray mammography to identify relevant pathologies in subjects with dense breast issue (BI-RADS density categories C and D) otherwise not detected in scans produced with conventional mammography. [Likert scale 1-3. Higher score is a better outcome] | End of visit 1 (or up to 7 days following visit 1, if needed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Grimm, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
Data is confidential and proprietary. Sponsor permission is required to share data.
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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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| Lower breast compression with monochromatic-based x-ray mammography | Assess ability of monochromatic-based x-ray mammography to produce quality images with lower breast compression. [Likert scale 1-3. Higher score is a better outcome] | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) |
| Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose. | Demonstrate ability of monochromatic-based mammography to produce quality images at radiation doses below maximum FDA-approved radiation dose. [Likert scale 1-3. Higher score is a better outcome] | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) |
| Patient satisfaction with monochromatic x-ray mammography system | Assess patient satisfaction with monochromatic x-ray mammography system. [Likert scale 1-5. Higher score is a better outcome.] | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) |
| D017437 |
| Skin and Connective Tissue Diseases |