Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology

The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer

Detailed Description

The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects arriving for a mammography or breast ultrasound

Description

Inclusion Criteria:

• Gender: female
• Age: 50 years and older
• Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
• Subject who have signed an informed consent form.

Exclusion Criteria:

• Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager.
• Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
• Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
• Subjects who have undergone a mastectomy.
• Subjects who have undergone a lumpectomy.
• Subjects who have a large scar (causing breast deformation).
• Subjects who have previously undergone or are currently undergoing breast radiation therapy.
• Subjects who have previously undergone or are currently undergoing chemotherapy.
• Subjects with prior breast reduction surgery or breast augmentation surgery.
• Subjects who are pregnant.
• Subjects who are breast-feeding.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Real Imaging Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (Estimate): December 10, 2009

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 960-PRL-002