Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System
- Conditions
- Breast Cancer
- Interventions
- Device: MIRA device imaging
- Registration Number
- NCT02155075
- Lead Sponsor
- Real Imaging Ltd.
- Brief Summary
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.
The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 730
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 MIRA device imaging Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant. All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI. Arm 2 MIRA device imaging Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path.
- Primary Outcome Measures
Name Time Method Sufficient number of cancer case and controls have been imaged up to 24 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Chaim Sheba Medical Center at Tel Hashomer
🇮🇱Ramat-Gan, Israel