Breast Cancer, Breast Imaging
Conditions
Keywords
Mammography
Brief summary
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.
Detailed description
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.
Interventions
DEVICE2-D Monochromatic X-ray Mammography System
Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
Sponsors
Imagine Scientific, Inc.
Duke Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 40 yrs of age or older * Capable of giving informed consent * Prior history of mammography
Exclusion criteria
* Pregnancy * History of breast cancer surgery, including lumpectomy or mastectomy * Currently undergoing treatment for breast cancer * Previous breast augmentations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) | 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. \[Likert scale 1-3. Higher score is a better outcome\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography | End of visit 1 (or up to 7 days following visit 1, if needed) | 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. \[Likert scale 1-3. Higher score is a better outcome\] |
| Lower breast compression with monochromatic-based x-ray mammography | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) | Assess ability of monochromatic-based x-ray mammography to produce quality images with lower breast compression. \[Likert scale 1-3. Higher score is a better outcome\] |
| Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose. | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) | Demonstrate ability of monochromatic-based mammography to produce quality images at radiation doses below maximum FDA-approved radiation dose. \[Likert scale 1-3. Higher score is a better outcome\] |
| Patient satisfaction with monochromatic x-ray mammography system | Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed) | Assess patient satisfaction with monochromatic x-ray mammography system. \[Likert scale 1-5. Higher score is a better outcome.\] |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLars Grimm, MD
Duke Health
Outcome results
None listed