Status:
COMPLETED
Collection of Raw Data of Thermal Imaging 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 in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early det...
Eligibility Criteria
Inclusion
- Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT00750464
Start Date
November 1 2008
End Date
August 1 2009
Last Update
October 14 2009
Active Locations (4)
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1
Carmel Medical Center - Lin
Haifa, Israel
2
Hadassah Medical Organization
Jerusalem, Israel
3
Meir Medical Center
Kfar Saba, Israel
4
Rabin Medical Center
Petah Tikva, Israel