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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01277263
• Other study ID #: 20107789
• Status: Withdrawn
• Start date: December 2010
• Est. completion date: December 2018

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Diffuse Optical Spectroscopy Imaging
Monitoring Breast Cancer during chemo therapy

Locations

Country	Name	City	State
United States	Pacific Breast Care Medical Clinic	Costa Mesa	California
United States	Beckman Laser Institute	Irvine	California
United States	Chao Family Comprehensive Cancer Center, UCIMC	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improve treatment prognosis for breast cancer patients	The proposed research plan has the ability to significantly impact breast cancer research and treatment	12 weeks