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Infrared Imaging (Breast Scan IR) for Early Breast Cancer Detection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195026
First Posted: September 19, 2005
Last Update Posted: March 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Weill Medical College of Cornell University
  Purpose
This protocol will evaluate a new non-invasive infrared imaging system as an adjunctive tool for breast cancer detection that has been approved by the FDA. The technology and device have been developed by Infrared Sciences Corp. and has undergone more than 3 years of testing prior. The subject device's utility will be investigated with regard to its sensitivity toward breast cancer, however it records temperature data and other physiological parameters of the breast, and compares them to a database of patients with known breast health.

Condition Intervention
Breast Cancer Device: Infrared Breast Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Infrared Imaging (Breast Scan IR) for Early Breast Cancer Detection

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment: 200
Study Start Date: March 2005
Intervention Details:
    Device: Infrared Breast Scan
    Patients already scheduled for breast biopsies will receive an additional infrared scan
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients already recommended for breast biopsy
Criteria

Inclusion Criteria:

  • Mammographic Breast Abnormality requiring a follow up biopsy
  • Sonographic Breast Abnormality requiring a follow up biopsy
  • Clinical Breast Abnormality requiring a follow up biopsy

Exclusion Criteria:

  • Active Breast Inflammation
  • Previous history of breast augmentation
  • Bra size greater than DD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195026


Locations
United States, New York
Weill Cornell Breast Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michael Osborne, MD NY Presbyterian Hospital Weill Cornell Breast Center
  More Information

Responsible Party: Dr. Rache Simmons, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00195026     History of Changes
Other Study ID Numbers: 0309006370
First Submitted: September 14, 2005
First Posted: September 19, 2005
Last Update Posted: March 18, 2008
Last Verified: March 2008

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