Breast Cancer
Conditions
Keywords
Mammography
Brief summary
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.
Detailed description
Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
Interventions
DEVICEFull Field Digital Mammogram (Planmed Sophie Nuance)
Full Field Digital Mammogram
Sponsors
Planmed Oy
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is 40 years of age or older 2. Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II) 3. Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams 4. Subject will provide prospective, written informed consent 5. Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -
Exclusion criteria
1. Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months 2. Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures? Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year 3. Subject has had an invasive breast procedure or operation within the past year 4. Subject has significant existing breast trauma 5. Subject has a history of breast cancer treated with operation or radiation 6. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer | Approximately one year after completion of study. |
Secondary
| Measure | Time frame |
|---|---|
| area under the ROC curve based on the POM scores from the ten regions of a subject's breasts; | Approximately one year after completion of study. |
| sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer; | Approximately one year after completion of study. |
| specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer; | Approximately one year after completion of study. |
| area under the ROC curve based on the maximum POM score per subject-breast | Approximately one year after completion of study. |
| Feature Analysis Study; side by side assessment of SFM and FFDM images and comparison of quality features: lesion conspicuity, tissue visibility at chest wall, tissue visibility at skin line, axillary details (MLO), overall contrast, overall sharpness | Approximately one year after completion of study. |
| Adverse event assessment | Approximately 24 hours after completion of FFDM |
| Sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 4 or higher for positive; and sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 3 or higher for positive. | Approximately one year after completion of study. |
Countries
United States
Outcome results
None listed