Optical Tomography With Ultrasound Guidance

NCT00908609 | Completed DMC

• 2 other identifiers: 02-064S-2R01EB002136
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer Diagnosis; Optical Imaging; Ultrasound Imaging; Monitoring Neoadjuvant Chemotherapy Response

Outcome Measures

Primary Outcomes (1)

• 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.

  4 more years

Study Arms (2)

1

Patients who undergo routine ultrasound guided biopsy will be studied by optical imaging technique.

2

Patients who have advanced breast cancers and are under neoadjuvant chemotherapy treatment will be studied by optical technique.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Women undergo ultrasound guided biopsy 2. Breast cancer patients undergo neoadjuvant thermotherapy treatment

You may qualify if:

• Women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment

You may not qualify if:

• Women under 18 years old.

Sponsors & Collaborators

• UConn Health: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Donaghue Medical Research Foundation: collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (9)

• 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.

  PMID: 20571122 RESULT

• 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.

  PMID: 21198181 RESULT

• 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.

  PMID: 20615005 RESULT

• 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.

  PMID: 19725717 RESULT

• 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.

  PMID: 19021330 RESULT

• 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.

  PMID: 18813360 RESULT

• 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.

  PMID: 25349073 RESULT

• 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.

  PMID: 23296038 RESULT

• 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.

  PMID: 23264349 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Quing Zhu, Ph.D

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 27, 2009
• Study Start: April 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 17, 2017

Record last verified: 2015-05

Locations

US (2)