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

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195026
First received: September 14, 2005
Last updated: March 13, 2008
Last verified: March 2008
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Rache Simmons, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00195026     History of Changes
Other Study ID Numbers: 0309006370
Study First Received: September 14, 2005
Last Updated: March 13, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013