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Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
This study has been withdrawn prior to enrollment.
(Re-definition of MIRA technology goals.)
Sponsor:
Real Imaging Ltd.
Information provided by (Responsible Party):
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01029977
First received: December 9, 2009
Last updated: April 25, 2017
Last verified: May 2015
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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.:
| Enrollment: | 0 |
| Anticipated Study Start Date: | May 2015 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029977
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029977
Locations
| Israel | |
| Hadassah Medical Center | |
| Jerusalem, Israel | |
Sponsors and Collaborators
Real Imaging Ltd.
More Information
| Responsible Party: | 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: | April 25, 2017 |
ClinicalTrials.gov processed this record on July 19, 2017