Near Infrared/ Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis

NCT00499980 | Completed DMC

• 1 other identifier: OSU-04117
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions

Conditions

Breast Neoplasms

Keywords

Breast cancer; Spectroscopy, Near-Infrared; Oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Non-pregnant (as defined by previous tubal ligation, no menses for last 12 consecutive months, or a negative quantitative serum pregnancy test on the day of the procedure.)
• Age: 18 years or older
• Suspicious lesion (BIRAD 4 or 5) identified by mammography and/or by ultrasound.
• A breast biopsy has been scheduled
• The suspicious lesion size is between 0.5 cm and 2 cm.
• The suspicious lesion depth is less than 3 cm from skin surface.
• The suspicious lesion should be clearly evident by ultrasound imaging

You may not qualify if:

• Patient with the biopsy performed to the suspicious lesion in the past 2 months on the same breast will be excluded from the study
• Patient with tattoos overlying the area of the suspicious lesion will be excluded from the study
• Patients with prior breast radiation therapy will be excluded from the study
• Patients with prior breast reduction surgery or breast augmentation surgery to the same breast will be excluded from the study
• Patients with previous surgical biopsy at or near the site of the suspicious lesion will be excluded from the study
• Patients with prior history of breast cancer in the same breast will be excluded from the study
• Patient who does not sign the consent form will be excluded from the study
• Patients that have not completed all studies of mammography and/or clinical ultrasound, P-Scan, Terason ultrasound and biopsy will be excluded from this study.

Sponsors & Collaborators

• Ohio State University: lead
• ViOptix Canada: collaborator

Study Sites (1)

JamesCare Breast Health Center

Dublin, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ronald X Xu, PhD

  Department of Biomedical Engineering, OSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 12, 2007
• Study Start: March 1, 2005
• Study Completion: August 1, 2005
• Last Updated: July 12, 2007

Record last verified: 2007-07

Locations

US (1)