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Optical Tomography With Ultrasound Guidance

This study has been completed.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Quing Zhu, UConn Health Identifier:
First received: May 22, 2009
Last updated: April 13, 2017
Last verified: May 2015

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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection

Resource links provided by NLM:

Further study details as provided by Quing Zhu, UConn Health:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 more years ]

Enrollment: 340
Study Start Date: April 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Patients who undergo routine ultrasound guided biopsy will be studied by optical imaging technique.
Patients who have advanced breast cancers and are under neoadjuvant chemotherapy treatment will be studied by optical technique.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Women undergo ultrasound guided biopsy
  2. Breast cancer patients undergo neoadjuvant thermotherapy treatment

Inclusion Criteria:

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

Exclusion Criteria:

  • Women under 18 years old.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00908609

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
UConn Health
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Donaghue Medical Research Foundation
Principal Investigator: Quing Zhu, Ph.D University of Connecticut
  More Information


Responsible Party: Quing Zhu, Professor, UConn Health Identifier: NCT00908609     History of Changes
Other Study ID Numbers: 02-064S-2
R01EB002136 ( US NIH Grant/Contract Award Number )
Study First Received: May 22, 2009
Last Updated: April 13, 2017

Keywords provided by Quing Zhu, UConn Health:
Breast Cancer Diagnosis
Optical Imaging
Ultrasound Imaging
Monitoring Neoadjuvant Chemotherapy Response

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on June 26, 2017