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

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT01029977
• Lead Sponsor: Real Imaging Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Status Verified: 2015-05
• Study Start: 2015-05
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel