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3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



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

Exclusion Criteria:

- Women under 18 years old.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

4 more years

Safety Issue:

No

Principal Investigator

Quing Zhu, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut

Authority:

United States: Institutional Review Board

Study ID:

02-064S-2

NCT ID:

NCT00908609

Start Date:

April 2007

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer Diagnosis
  • Optical Imaging
  • Ultrasound Imaging
  • Monitoring Neoadjuvant Chemotherapy Response
  • Breast Neoplasms

Name

Location

Hartford HospitalHartford, Connecticut  06102-5037
University of Connecticut Health CenterFarmington, Connecticut  06360-7106