Evaluation of a Novel Infra-red Breast Imaging System for Breast Cancer Risk Assessment in Women With Breast Implants
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.
The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
Another group of women for whom screening mammography is sub-optimal are women with breast implants. There is reason to believe that 3D MIRA technology can be applied successfully for breast cancer screening in women with implants.
The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in augmented women.
The investigators hypothesize that the presence of breast implants will not affect the ability of this new technology to correctly classify healthy women and breast cancer patients.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Data Collection Study for the Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women With Breast Implants.|
- Sufficient number of cancer case and controls have been imaged [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02155075
|Contact: MIri Sklair-Levy, MD||972-3-5302514||Miri.SklairLevy@sheba.health.gov.il|
|The Chaim Sheba Medical Center at Tel Hashomer||Recruiting|
|Ramat-Gan, Israel, 5262000|
|Contact 972-3-5302514 Miri.SklairLevy@sheba.health.gov.il|
|Principal Investigator: Miri Sklair-Levy, MD|
|Principal Investigator:||Miri Sklair-Levy, MD||The Chaim Sheba Medical center at Tel-Hashomer|