Breast Cancer
Conditions
Keywords
Breast neoplasm, Breast implants, Mammography, Breast imaging, Imaging augmented breast
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.
Interventions
DEVICEMIRA device imaging
MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result
Sponsors
Real Imaging Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PHASE 1: INCLUSION CRITERIA 1. Female 2. Woman has read, understood and signed the inform consent form 3. Age: 30 years and older 4. A. Women who are scheduled to undergo routine Mammography and/or US and/or MRI screening OR B. Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale
Exclusion criteria
1. Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan 2. Women who had undergone mastectomy and/or breast reconstruction 3. Women who have had a breast biopsy performed throughout the 6 weeks preceding the study 4. Women who have a fever on the day of the MIRA imaging 5. Women who are pregnant 6. Women who are breast-feeding 7. Women with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area 8. Women who are unable to read, understand and execute written informed consent 9. Women who are currently undergoing chemotherapy and/or radiotherapy PHASE 2: ARM 1: INCLUSION CRITERIA 1. Female 2. Age: 30 years and older 3. A. Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US Or B. Subjects scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI). 5\. Women whose most recent prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Contacts
Primary ContactMIri Sklair-Levy, MD
Outcome results
None listed