Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging
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|ClinicalTrials.gov Identifier: NCT01277263|
Recruitment Status : Withdrawn (Not a Clinical Trial study)
First Posted : January 14, 2011
Last Update Posted : August 31, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Diffuse Optical Spectroscopy Imaging|
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 Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Device: Diffuse Optical Spectroscopy Imaging
- 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277263
|United States, California|
|Pacific Breast Care Medical Clinic|
|Costa Mesa, California, United States, 92627|
|Beckman Laser Institute|
|Irvine, California, United States, 92612|
|Chao Family Comprehensive Cancer Center, UCIMC|
|Orange, California, United States, 92868|
|Study Director:||Bruce Tromberg, PhD||Beckman Laser Institute|