Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Real Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT02009150
First received: December 7, 2013
Last updated: March 13, 2014
Last verified: December 2013

December 7, 2013
March 13, 2014
March 2014
February 2017   (final data collection date for primary outcome measure)
Percentage of breast cancer cases detected by the new medical device (the 3D MIRA technology) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02009150 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Women who are determined to have high risk of breast cancer and who are screened biannually by existing screening modalities (mammography, ultrasound or MRI)

Breast Cancer
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Women at high risk for breast cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
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February 2017   (final data collection date for primary outcome measure)

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 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 up to 5 years preceding the study
  • 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 6 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
Female
20 Years and older
Yes
Israel
 
NCT02009150
960-CSP-ISR_HighRiskMC_ILS1
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Real Imaging Ltd.
Real Imaging Ltd.
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Not Provided
Real Imaging Ltd.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP