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Optical Tomography With Ultrasound Guidance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00908609
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Breast Cancer

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.


Study Design

Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection
Study Start Date : April 2007
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908609


Locations
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
Investigators
Principal Investigator: Quing Zhu, Ph.D University of Connecticut
More Information

Publications:

Responsible Party: Quing Zhu, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT00908609     History of Changes
Other Study ID Numbers: 02-064S-2
R01EB002136 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: May 2015

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
Neoplasms
Breast Diseases
Skin Diseases