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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02009150
First Posted: December 11, 2013
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Real Imaging Ltd.
December 7, 2013
December 11, 2013
September 19, 2017
April 2014
July 2017   (Final data collection date for primary outcome measure)
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 ]
Percentage of breast cancer cases detected by the new medical device (the 3D MIRA technology) [ Time Frame: up to 36 months ]
Complete list of historical versions of study NCT02009150 on ClinicalTrials.gov Archive Site
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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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
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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
236
July 2018
July 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 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
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02009150
960-CSP-ISR_HighRiskMC_ILS1
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Real Imaging Ltd.
Real Imaging Ltd.
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Principal Investigator: Miri Sklair-Levy, MD The Chaim Sheba Medical center at Tel-Hashomer
Real Imaging Ltd.
March 2017