Optical Tomography With Ultrasound Guidance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Connecticut Health Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Quing Zhu, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00908609
First received: May 22, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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
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 University of Connecticut Health Center:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: April 2007
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Connecticut Health Center
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, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00908609     History of Changes
Other Study ID Numbers: 02-064S-2, R01EB002136
Study First Received: May 22, 2009
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
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

ClinicalTrials.gov processed this record on October 19, 2014