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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
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.:
Estimated Enrollment: 50
Study Start Date: August 2011
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
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

Contacts
Contact: Tamar Sela, MD 972-(0)50-7874180 tamarse@hadassah.org.il

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Principal Investigator: Tamar Sela, MD         
Sponsors and Collaborators
Real Imaging Ltd.
  More Information

No publications provided

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: June 26, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on March 02, 2015