Evaluation of a Novel Infra-red Breast Imaging System for Breast Cancer Risk Assessment in Women With Breast Implants

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Real Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT02155075
First received: June 1, 2014
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.

The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

Another group of women for whom screening mammography is sub-optimal are women with breast implants. There is reason to believe that 3D MIRA technology can be applied successfully for breast cancer screening in women with implants.

The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in augmented women.

The investigators hypothesize that the presence of breast implants will not affect the ability of this new technology to correctly classify healthy women and breast cancer patients.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Data Collection Study for the Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women With Breast Implants.

Resource links provided by NLM:


Further study details as provided by Real Imaging Ltd.:

Primary Outcome Measures:
  • Sufficient number of cancer case and controls have been imaged [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.


Estimated Enrollment: 300
Study Start Date: July 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women aged 30 years and older, who have breast implants and who, regardless of this clinical trial are summoned for routine breast cancer screening exam or breast biopsy due to suspicious finding in recent screening exam.

Criteria

Inclusion Criteria:

  • Female
  • Woman has read, understood and signed the inform consent form
  • Age: 30 years and older
  • Woman has breast implants
  • Women who are asymptomatic and are scheduled to undergo routine Mx and/or US screening OR Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5/6 on BI-RADS scale

Exclusion Criteria:

  • Women who have had a Mx and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
  • Women who had a lumpectomy surgery preceding the study
  • Women who had undergone mastectomy and/or breast reconstruction
  • Women who have undergone any type of breast surgery 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 with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
  • Women who are unable to read, understand and execute written informed consent
  • Women who are currently undergoing chemotherapy and/or radiotherapy
  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: NCT02155075

Contacts
Contact: MIri Sklair-Levy, MD 972-3-5302514 Miri.SklairLevy@sheba.health.gov.il

Locations
Israel
The Chaim Sheba Medical Center at Tel Hashomer Not yet recruiting
Ramat-Gan, Israel, 5262000
Contact    972-3-5302514    Miri.SklairLevy@sheba.health.gov.il   
Principal Investigator: Miri Sklair-Levy, MD         
Sponsors and Collaborators
Real Imaging Ltd.
Investigators
Principal Investigator: Miri Sklair-Levy, MD The Chaim Sheba Medical center at Tel-Hashomer
  More Information

No publications provided

Responsible Party: Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT02155075     History of Changes
Other Study ID Numbers: 960-CSP-ISR_ImplantsMC_ILS3
Study First Received: June 1, 2014
Last Updated: June 3, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Real Imaging Ltd.:
Breast neoplasm
Breast implants
Mammography
Breast imaging
Imaging augmented breast

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

ClinicalTrials.gov processed this record on July 22, 2014