Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
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ClinicalTrials.gov Identifier: NCT01029977 |
Recruitment Status
:
Withdrawn
(Re-definition of MIRA technology goals.)
First Posted
: December 10, 2009
Last Update Posted
: April 27, 2017
|
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Estimated Study Start Date : | May 2015 |
Estimated Primary Completion Date : | May 2016 |
Estimated Study Completion Date : | December 2016 |

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029977
Israel | |
Hadassah Medical Center | |
Jerusalem, Israel |
Responsible Party: | Real Imaging Ltd. |
ClinicalTrials.gov Identifier: | NCT01029977 History of Changes |
Other Study ID Numbers: |
960-PRL-002 |
First Posted: | December 10, 2009 Key Record Dates |
Last Update Posted: | April 27, 2017 |
Last Verified: | May 2015 |