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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This study has been withdrawn prior to enrollment.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:
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01029977
First received: December 9, 2009
Last updated: May 4, 2015
Last verified: May 2015
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Real Imaging Ltd.:
Enrollment: 0
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
Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders 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

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Real Imaging Ltd.
  More Information

Responsible Party: Mr. Boaz Arnon, CEO, 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: May 4, 2015
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on September 28, 2016