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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This study has been withdrawn prior to enrollment.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:
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
December 9, 2009
April 25, 2017
May 2015
May 2016   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01029977 on ClinicalTrials.gov Archive Site
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Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
Not Provided
The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.
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.
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample
Subjects arriving for a mammography or breast ultrasound
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2016
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01029977
960-PRL-002
No
Not Provided
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Real Imaging Ltd.
Real Imaging Ltd.
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Not Provided
Real Imaging Ltd.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP