Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Real Imaging Ltd..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Real Imaging Ltd.
Information provided by:
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01029977
First received: December 9, 2009
Last updated: June 26, 2011
Last verified: December 2009
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Purpose
The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
Resource links provided by NLM:
Further study details as provided by Real Imaging Ltd.:
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects arriving for a mammography or breast ultrasound
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029977
Contacts
| Contact: Tamar Sela, MD | 972-(0)50-7874180 | tamarse@hadassah.org.il |
Locations
| Israel | |
| Hadassah Medical Center | Not yet recruiting |
| Jerusalem, Israel | |
| Principal Investigator: Tamar Sela, MD | |
Sponsors and Collaborators
Real Imaging Ltd.
More Information
No publications provided
| Responsible Party: | Mr. Boaz Arnon, CEO, Real Imaging Ltd. |
| ClinicalTrials.gov Identifier: | NCT01029977 History of Changes |
| Other Study ID Numbers: | 960-PRL-002 |
| Study First Received: | December 9, 2009 |
| Last Updated: | June 26, 2011 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013