Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor University of Connecticut Health Center
Collaborator National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Start date April 2007
End date August 2013
Trial size 340 participants
Trial identifier NCT00908609, 02-064S-2, R01EB002136

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
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

Female participants at least 18 years old.

Inclusion Criteria: - Women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment Exclusion Criteria: - Women under 18 years old.

Additional Information

Official title 3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection
Principal investigator Quing Zhu, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University of Connecticut Health Center.