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
Sponsor:
Information provided by:
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01029977
First received: December 9, 2009
Last updated: June 26, 2011
Last verified: December 2009

December 9, 2009
June 26, 2011
August 2011
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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
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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.
 
Not yet recruiting
50
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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.
Female
50 Years and older
Yes
Contact: Tamar Sela, MD 972-(0)50-7874180 tamarse@hadassah.org.il
Israel
 
NCT01029977
960-PRL-002
No
Mr. Boaz Arnon, CEO, Real Imaging Ltd.
Real Imaging Ltd.
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Real Imaging Ltd.
December 2009

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