N/A
50 Years
N/A
50 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
The objective of the current clinical study is to collect sufficient MIRA imaging data of
subjects arriving for a routine screening mammography, before and after they undergo the
mammography. This is in order to reach a conclusion whether the the firm breast compression
involved in the mammography procedure affects the performance of the MIRA technology. At the
current stage of the development of the device, the goal of this clinical trial is in no way
to arrive at a statistical analysis.
Inclusion Criteria:
- Gender: female
- Age: 50 years and older
- Subjects summoned for a routine screening mammography, ultrasound, diagnostic
mammography or breast biopsy.
- 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 their FIRST imaging session with the RealImager.
- 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 undergone a lumpectomy.
- Subjects who have a large scar (causing breast deformation).
- Subjects who have previously undergone or are currently undergoing breast radiation
therapy.
- Subjects who have previously undergone or are currently undergoing chemotherapy.
- Subjects with prior breast reduction surgery or breast augmentation surgery.
- Subjects who are pregnant.
- Subjects who are breast-feeding.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Authority:
Israel: Ministry of Health
Study ID:
960-PRL-002
NCT ID:
NCT01029977
Start Date:
August 2011
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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