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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:
Information provided by (Responsible Party):
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT02009150
First received: December 7, 2013
Last updated: March 7, 2017
Last verified: March 2017
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Real Imaging Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 236
Study Start Date: April 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who are determined to have high risk of breast cancer and who are screened biannually by existing screening modalities (mammography, ultrasound or MRI)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009150

Locations
Israel
The Chaim Sheba Medical Center at Tel-Hashomer
Ramat-Gan, Israel, 5262000
Sponsors and Collaborators
Real Imaging Ltd.
Investigators
Principal Investigator: Miri Sklair-Levy, MD The Chaim Sheba Medical center at Tel-Hashomer
  More Information

Responsible Party: Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT02009150     History of Changes
Other Study ID Numbers: 960-CSP-ISR_HighRiskMC_ILS1
Study First Received: December 7, 2013
Last Updated: March 7, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 27, 2017