Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer

February 7, 2012 updated by: Real Imaging Ltd.

Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1827

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Ein Kerem Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Ramat Gan, Israel
        • Sheba medical center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Assuta Ramat Hachayal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.

Description

Inclusion Criteria:

  • Gender: female
  • Age: 18 years and older
  • Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
  • 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 being "imaged" by RI4.0.
  • 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 a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
  • Subjects with prior breast reduction surgery or breast augmentation surgery.
  • Subjects who have a fever on the day of their biopsy.
  • Subjects who are pregnant.
  • Subjects who are breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Real Imaging Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (ESTIMATE)

January 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pr-118-8061 ver. 004
  • QMS number: 960-PRL-09011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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