Study Results
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Basic Information
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COMPLETED
340 participants
OBSERVATIONAL
2007-04-30
2012-01-31
Brief Summary
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As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a small group of patients who underwent biopsy have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.
The objective of this study is to validate the investigators' initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.
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Detailed Description
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Objective 1: Validate the sensitivity, specificity, positive predictive value and negative predictive value of optical tomography/US for distinguishing benign and early stage malignant breast tumors. Approximately 300 patients who will undergo ultrasound-guided biopsy are being recruited to this study from the University of Connecticut Health Center and Hartford Hospital. The total hemoglobin concentration and blood oxygen saturation will be the measured indices and the biopsy results will be used as the 'gold' standard.
Objective 2: Perform pilot studies of optical tomography/US to assess chemotherapy response and evaluate treatment efficacy. Patients diagnosed with locally advanced breast cancers (size greater than 3 cm) who will undergo chemotherapy will be enrolled to this study. Approximately, 20 to 30 patients are being recruited to the study from the University of Connecticut Health Center and Hartford Hospital.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients who undergo routine ultrasound guided biopsy will be studied by optical imaging technique.
No interventions assigned to this group
2
Patients who have advanced breast cancers and are under neoadjuvant chemotherapy treatment will be studied by optical technique.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Donaghue Medical Research Foundation
OTHER
UConn Health
OTHER
Responsible Party
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Quing Zhu
Professor
Principal Investigators
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Quing Zhu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Connecticut
Locations
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University of Connecticut Health Center
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Countries
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References
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Zhu Q, Hegde PU, Ricci A Jr, Kane M, Cronin EB, Ardeshirpour Y, Xu C, Aguirre A, Kurtzman SH, Deckers PJ, Tannenbaum SH. Early-stage invasive breast cancers: potential role of optical tomography with US localization in assisting diagnosis. Radiology. 2010 Aug;256(2):367-78. doi: 10.1148/radiol.10091237. Epub 2010 Jun 22.
Xu Y, Zhu Q. Imaging heterogeneous absorption distribution of advanced breast cancer by optical tomography. J Biomed Opt. 2010 Nov-Dec;15(6):066007. doi: 10.1117/1.3505015.
Xu C, Zhu Q. Light shadowing effect of large breast lesions imaged by optical tomography in reflection geometry. J Biomed Opt. 2010 May-Jun;15(3):036003. doi: 10.1117/1.3431086.
Ardeshirpour Y, Huang M, Zhu Q. Effect of the chest wall on breast lesion reconstruction. J Biomed Opt. 2009 Jul-Aug;14(4):044005. doi: 10.1117/1.3160548.
Xu C, Yuan B, Zhu Q. Optimal probe design for breast imaging using near-infrared diffused light. J Biomed Opt. 2008 Jul-Aug;13(4):044002. doi: 10.1117/1.2966703.
Zhu Q, Tannenbaum S, Hegde P, Kane M, Xu C, Kurtzman SH. Noninvasive monitoring of breast cancer during neoadjuvant chemotherapy using optical tomography with ultrasound localization. Neoplasia. 2008 Oct;10(10):1028-40. doi: 10.1593/neo.08602.
Zhu Q, Wang L, Tannenbaum S, Ricci A Jr, DeFusco P, Hegde P. Pathologic response prediction to neoadjuvant chemotherapy utilizing pretreatment near-infrared imaging parameters and tumor pathologic criteria. Breast Cancer Res. 2014 Oct 28;16(5):456. doi: 10.1186/s13058-014-0456-0.
Tavakoli B, Zhu Q. Two-step reconstruction method using global optimization and conjugate gradient for ultrasound-guided diffuse optical tomography. J Biomed Opt. 2013 Jan;18(1):16006. doi: 10.1117/1.JBO.18.1.016006.
Zhu Q, DeFusco PA, Ricci A Jr, Cronin EB, Hegde PU, Kane M, Tavakoli B, Xu Y, Hart J, Tannenbaum SH. Breast cancer: assessing response to neoadjuvant chemotherapy by using US-guided near-infrared tomography. Radiology. 2013 Feb;266(2):433-42. doi: 10.1148/radiol.12112415. Epub 2012 Dec 21.
Other Identifiers
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02-064S-2
Identifier Type: -
Identifier Source: org_study_id
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