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Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging


N/A
21 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging


Diffuse Optical Spectroscopic Imaging (DOSI) can measure predict markers of response in the
first weeks of therapy.The oxyhemoglobin flare response can predictive of overall
pathological response to chemotherapy in human subjects. These vascular changes can indicate
the rapid transient increase and then decrease in oxyhemoglobin concentration (which is
measurable with DOSI) in the first hours and days after therapeutic administration. The
magnitude and time course of the flare response in patients receiving cytotoxic therapy will
differ between pathological responders and non-responders. This oxyhemoglobin "flare
response" can be observed In tumors where vascular dynamics are intact.


Inclusion Criteria:



- Female, not pregnant, not breastfeeding

- greater than 21 years of age but less than 75 years of age

- will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their
oncologist

Exclusion Criteria:

- Under 21 year of age

- Female pregnant or breastfeeding

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

improve treatment prognosis for breast cancer patients

Outcome Description:

The proposed research plan has the ability to significantly impact breast cancer research and treatment

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

David Hsiang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Laser Institute

Authority:

United States: Institutional Review Board

Study ID:

DOD No. BC097812

NCT ID:

NCT01277263

Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location
Beckman Laser Institute Irvine, California  92612