A Data Collection Study for the Evaluation of Real Imaging's Real Imager 8 (RI-8) Developed for Risk Assessment of Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Real Imaging Ltd.
- Locations
- 1
- Primary Endpoint
- Sufficient number of cancer case and controls have been imaged
Study Overview
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.
Real Imaging is continuously developing the technology including image acquisition hardware and objective analysis of the imaging biomarkers. To further improve and optimize this novel metabolic imaging technology, Real Imaging will introduce an improved imaging device.
The purpose of this clinical study is to collect more imaging data in order to establish superiority of the newer device over the previous one.
The investigators hypothesize is that the new device will be at least as good as the previous one.
Detailed Description
Breast cancer remains a leading cause of cancer death among women, with an estimated 1 million new cases and over 400,000 deaths annually worldwide.
In recent years, however, improvements in survival rate have been attributed to earlier diagnosis by national screening programs and better treatments. Although mammography has been the main screening modality of early detection, its limitations such as difficulty in interpreting mammograms for woman with dense breast, are well recognized and the search for more effective technologies for early detection has been receiving increased attention.
Previous studies showed that US (Ultra Sound) can detect more breast cancers not seen on Mammography, particularly in dense breasts. However, breast US sensitivity is not very high and it is highly operator-dependent.
As opposed to US, Breast MRI is highly sensitive, however, it is not used as a screening tool for the general population. The high cost of MRI, its relatively low specificity (true negative rate), its being time consuming and its need for intravenous contrast agent make it unsuitable as a breast screening tool for the general population.
In light of these shortcomings, the use of the existing screening modalities described that are based on anatomical imaging will result in some misdiagnosis of cancer, particularly in women with dense breast tissue.There is a real need for a novel breast imaging technology that may outperform the current modalities available for women.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Woman has read, understood and signed the inform consent form
- •Age: 30 years and older
- •Women who are asymptomatic and are scheduled to undergo routine Mx and/or US screening OR Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5/6 on BI-RADS scale
Exclusion Criteria
- •Women who have had a Mx (mammography) and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
- •Women who had a lumpectomy surgery preceding the study
- •Women who had undergone mastectomy and/or breast reconstruction
- •Women who have undergone any type of breast surgery preceding the study
- •Women who have had a breast biopsy performed throughout the 10 weeks preceding the study
- •Women who have a fever on the day of the MIRA imaging
- •Women who are pregnant
- •Women who are breast-feeding
- •Women with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
- •Women who are unable to read, understand and execute written informed consent
- •Women who are have had chemotherapy and/or radiotherapy throughout the 6 months preceding the study
Outcomes
Primary Outcomes
Sufficient number of cancer case and controls have been imaged
Time Frame: up to 12 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 Outcomes
No secondary outcomes reported