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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01029977
• Other study ID #: 960-PRL-002
• Status: Withdrawn
• Phase: N/A
• First received: December 9, 2009
• Last updated: April 25, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Real Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Real Imaging Ltd.

Country where clinical trial is conducted

Israel,