Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499980
Status:
COMPLETED
Last Update Posted:
2007-07-12
First Post:
2007-07-11
Brief Title:
Near Infrared Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIR
Brief Summary:
The purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None