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A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions


N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Ronald X Xu, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Biomedical Engineering, OSU

Authority:

United States: Institutional Review Board

Study ID:

OSU-04117

NCT ID:

NCT00499980

Start Date:

March 2005

Completion Date:

August 2005

Related Keywords:

  • Breast Neoplasms
  • Breast cancer
  • Spectroscopy, Near-Infrared
  • Oximetry
  • Breast Neoplasms
  • Neoplasms

Name

Location

JamesCare Breast Health CenterDublin, Ohio  43210