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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01029977
First Posted: December 10, 2009
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Real Imaging Ltd.
  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)
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.
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

Responsible Party: Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01029977     History of Changes
Other Study ID Numbers: 960-PRL-002
First Submitted: December 9, 2009
First Posted: December 10, 2009
Last Update Posted: April 27, 2017
Last Verified: May 2015