Near Infrared/ Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis (NIR)

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. Identifier: NCT00499980
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
ViOptix Canada
Information provided by:
Ohio State University

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

Condition or disease
Breast Neoplasms

Detailed Description:

Breast cancer is the leading cause of cancer among women in the United States. It has always been the hope that devising methods of earlier detection would lead to improvement of long-term survival. Therefore, the development of novel, more selective, and noninvasive diagnostic techniques is a priority. Mammography is currently the most commonly used breast imaging modality for both screening and diagnostic purposes. Additionally, breast ultrasound imaging and breast magnetic resonance imaging (MRI) are generally used to supplement or help confirm any indeterminate or suspicious finding prior to consideration of a breast biopsy. However, these conventional imaging methods lack information about tissue function and have lower diagnostic accuracy.

Most recently, near infrared (NIR, of wavelength 700-900 nm) optical diffuse spectroscopic imaging has been investigated as a novel diagnostic tool for breast cancer. In the near-infrared (NIR) light spectrum, oxygenated hemoglobin and deoxygenated hemoglobin are the major chromospheres in tissue, and the absorption spectrums of the two hemoglobin states differ across these wavelengths. Thus, there have been many contemporary attempts to use the intra-tissue absorption and scattering of NIR light to quantify functional tissue parameters such as hemoglobin concentration (HbT) and oxygen saturation (StO2), including tumor differentiation within the human breast. To a very good approximation, NIR photons diffuse through relatively thick tissues, such as several centimeters of a human breast. Functional imaging with NIR light offers several novel tissue parameters that differentiate tumors from normal breast tissue. For example, hemoglobin de-saturation in tumors may be increased due to the high oxygen demand of cancers and blood volume may be increased over that of normal background tissue due to the greater vascularization and metabolic needs of cancers.

While NIR imaging provides additional physiological parameters that potentially help to improve the specificity of breast cancer diagnosis, its relatively low spatial resolution makes it unsuitable for morphological analysis. The resolution of a NIR system is intrinsically limited by the diffusive nature of the near infrared light in tissue. Currently, typical instruments can distinguish simple structures of approximately 1 cm in size; sharp edges are typically blurred by a few millimeters. It was proposed that the imaging technique combining near infrared and ultrasound modalities has the potential to fully utilize their complementary features and overcome their deficiencies. This protocol defines the clinical study to prove the concept of the near infrared/ ultrasound dual modal imaging and to evaluate its sensitivity and specificity for breast cancer diagnosis.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions
Study Start Date : March 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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 identifier (NCT number): NCT00499980

United States, Ohio
JamesCare Breast Health Center
Dublin, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
ViOptix Canada
Principal Investigator: Ronald X Xu, PhD Department of Biomedical Engineering, OSU Identifier: NCT00499980     History of Changes
Other Study ID Numbers: OSU-04117
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: July 2007

Keywords provided by Ohio State University:
Breast cancer
Spectroscopy, Near-Infrared

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