Status:
COMPLETED
Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
Lead Sponsor:
Real Imaging Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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")...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1827 Patients enrolled
Trial Details
Trial ID
NCT00821613
Start Date
September 1 2009
End Date
February 1 2012
Last Update
February 8 2012
Active Locations (6)
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1
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
2
Meir Medical Center
Kfar Saba, Israel
3
Rabin Medical Center
Petah Tikva, Israel
4
Sheba Medical Center
Ramat Gan, Israel