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

This study has been completed.
Sponsor:
Information provided by:
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00750464
First received: September 9, 2008
Last updated: October 12, 2009
Last verified: October 2009
  Purpose

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Real Imaging Ltd.:

Enrollment: 575
Study Start Date: November 2008
Study Completion Date: August 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy

Criteria

Inclusion Criteria:

  • Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.

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 RI3.0.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750464

Locations
Israel
Carmel Medical Center - Lin
Haifa, Israel
Hadassah Medical Organization
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Real Imaging Ltd.
Investigators
Principal Investigator: Miri Sklair-Levy, MD Hadassah Medical Organization, Jerusalem
  More Information

No publications provided

Responsible Party: Mr. Boaz Arnon, CEO, Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00750464     History of Changes
Other Study ID Numbers: Pr-118-8061 ver. 001
Study First Received: September 9, 2008
Last Updated: October 12, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014