Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT01277263
• Lead Sponsor: University of California, Irvine

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improve treatment prognosis for breast cancer patients	12 weeks	The proposed research plan has the ability to significantly impact breast cancer research and treatment

Trial Locations

Locations (3)

Chao Family Comprehensive Cancer Center, UCIMC; 🇺🇸 Orange, California, United States

Pacific Breast Care Medical Clinic; 🇺🇸 Costa Mesa, California, United States

Beckman Laser Institute; 🇺🇸 Irvine, California, United States