Collection of Raw Data of Thermal Imaging 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

NCT00750464

Pr-118-8061 ver. 001

Details and patient eligibility

About

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.

Enrollment: 575 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.

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 RI3.0.
• 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.