Near Infrared/ Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis

Completed

Conditions studied: Breast Neoplasms

In brief

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

Key facts

Study ID

NCT00499980

Run by

Ohio State University

People needed

50

Starts

2005-03-01

Expected to finish

2005-08-01

Last updated by the study team

2007-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• JamesCare Breast Health Center — Dublin, Ohio, United States

Full record on ClinicalTrials.gov

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