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

Real Imaging

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00821613

QMS number: 960-PRL-09011

Pr-118-8061 ver. 004

Details and patient eligibility

About

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.

Enrollment: 1,827 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.