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

NCT01029977 | Withdrawn

• 1 other identifier: 960-PRL-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects arriving for a mammography or breast ultrasound

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 27, 2017

Record last verified: 2015-05

Locations

IL (1)