Optical Tomography With Ultrasound Guidance
3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection
The investigators propose to validate the utility of their novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators' unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the optical tomography.
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Specific objectives of the study are:
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- University of Connecticut Health Center
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Hartford, Connecticut, Estados Unidos, 06102
- Hartford Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
- Women undergo ultrasound guided biopsy
- Breast cancer patients undergo neoadjuvant thermotherapy treatment
Descripción
Inclusion Criteria:
- Women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment
Exclusion Criteria:
- Women under 18 years old.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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1
Patients who undergo routine ultrasound guided biopsy will be studied by optical imaging technique.
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2
Patients who have advanced breast cancers and are under neoadjuvant chemotherapy treatment will be studied by optical technique.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The deoxygenated/oxygenated hemoglobin and total hemoglobin concentration are the measured imaging parameters and biopsy results will be used as the 'gold' standard to compare imaging findings.
Periodo de tiempo: 4 more years
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4 more years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Quing Zhu, Ph.D, University of Connecticut
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 02-064S-2
- R01EB002136 (Subvención/contrato del NIH de EE. UU.)
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