Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.
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|ClinicalTrials.gov Identifier: NCT02009150|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : September 19, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||236 participants|
|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|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
Women at high risk for breast cancer
Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models.
- Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer [ Time Frame: up to 36 months ]
- To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer. [ Time Frame: up to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009150
|The Chaim Sheba Medical Center at Tel-Hashomer|
|Ramat-Gan, Israel, 5262000|
|Principal Investigator:||Miri Sklair-Levy, MD||The Chaim Sheba Medical center at Tel-Hashomer|