Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00750464
- Lead Sponsor
- Real Imaging Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 575
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Carmel Medical Center - Lin
🇮🇱Haifa, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel