Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.
We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women at High Risk for Breast Cancer|
- Percentage of breast cancer cases detected by the new medical device (the 3D MIRA technology) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
|Women at high risk for breast cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009150
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Tamar Sela, MD firstname.lastname@example.org|
|Sheba Medical Center||Not yet recruiting|
|Ramat-Gan, Israel, 52621|
|Contact: Miri Sklair-Levy, MD email@example.com|