Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 3
- Primary Endpoint
- improve treatment prognosis for breast cancer patients
Overview
Brief Summary
Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome.
The Researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.
Detailed Description
The researcher can use Diffuse Optical Spectroscopic Imaging device to measure and predict the markers of the response in the first weeks of chemo-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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
improve treatment prognosis for breast cancer patients
Time Frame: 12 weeks
The proposed research plan has the ability to significantly impact breast cancer research and treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Beckman Laser Institute and Medical Center
Bruce Tromberg, PhD., Director, Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery
University of California, Irvine