A Data Collection Study for the Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment

NCT02505698 | Withdrawn

• 1 other identifier: 960-CLP-ISR-IR8
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. Real Imaging is continuously developing the technology including image acquisition hardware and objective analysis of the imaging biomarkers. To further improve and optimize this novel metabolic imaging technology, Real Imaging will introduce an improved imaging device. The purpose of this clinical study is to collect more imaging data in order to establish superiority of the newer device over the previous one. The investigators hypothesize is that the new device will be at least as good as the previous one.

Conditions

Breast Cancer

Keywords

Breast Imaging; Mammography; Anatomical Imaging

Outcome Measures

Primary Outcomes (1)

• Sufficient number of cancer case and controls have been imaged

  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.

  up to 12 months

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 30 years and older, 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.

You may qualify if:

• Female
• Woman has read, understood and signed the inform consent form
• Age: 30 years and older
• 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

You may not qualify if:

• Women who have had a Mx (mammography) 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 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 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 have had chemotherapy and/or radiotherapy throughout the 6 months preceding the study

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

The Breast Iamging Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Orit Golan, MD

  The Breast Imagning Unit at Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: July 22, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 11, 2018

Record last verified: 2017-03

Locations

IL (1)