3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
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
No
Quing Zhu, Ph.D
Principal Investigator
University of Connecticut
United States: Institutional Review Board
02-064S-2
NCT00908609
April 2007
August 2013
Name | Location |
---|---|
Hartford Hospital | Hartford, Connecticut 06102-5037 |
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |