- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009150
Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.
Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System 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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ramat-Gan, Israel, 5262000
- The Chaim Sheba Medical Center at Tel-Hashomer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Woman has read, understood and signed the inform consent form
- Age: 20 years and older
- Women who are asymptomatic 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
- Women scheduled to undergo routine mammography and/or US or MRI screening
Exclusion Criteria:
- Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
- Women who had a lumpectomy surgery
- Women who had undergone mastectomy and/or reconstruction
- Women who have undergone any type of breast surgery throughout the 6 months 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 who had undergone breast reduction/augmentation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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up to 36 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miri Sklair-Levy, MD, The Chaim Sheba Medical Center at Tel-Hashomer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 960-CSP-ISR_HighRiskMC_ILS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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