Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00821613
• Lead Sponsor: Real Imaging Ltd.

Brief Summary

Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Study Start: 2009-09
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1827

Inclusion Criteria

• Gender: female
• Age: 18 years and older
• Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
• 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 being "imaged" by RI4.0.
• 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 a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
• Subjects with prior breast reduction surgery or breast augmentation surgery.
• Subjects who have a fever on the day of their biopsy.
• Subjects who are pregnant.
• Subjects who are breast-feeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Hadassah Ein Kerem Medical Center; 🇮🇱 Jerusalem, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Assuta Ramat Hachayal Hospital; 🇮🇱 Tel Aviv, Israel