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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Recruitment Status : Withdrawn (Re-definition of MIRA technology goals.)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
Sponsor:
Information provided by (Responsible Party):
Real Imaging Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

Condition or disease
Breast Cancer

Detailed Description:
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.

Study Design
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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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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Real Imaging Ltd.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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