NCT00195026

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

March 18, 2008

Status Verified

March 1, 2008

First QC Date

September 14, 2005

Last Update Submit

March 13, 2008

Conditions

Breast Cancer

Interventions

Infrared Breast ScanDEVICE

Patients already scheduled for breast biopsies will receive an additional infrared scan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients already recommended for breast biopsy

You may qualify if:

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

You may not qualify if:

  • Active Breast Inflammation
  • Previous history of breast augmentation
  • Bra size greater than DD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Breast Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Osborne, MD

    NY Presbyterian Hospital Weill Cornell Breast Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

March 1, 2005

Last Updated

March 18, 2008

Record last verified: 2008-03

Locations

US(1)