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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277263

Enrollment

Registered

2011-01-14

Start date

2010-12-31

Completion date

2018-12-31

Last updated

2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer

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.

Interventions

DEVICEDiffuse Optical Spectroscopy Imaging

Monitoring Breast Cancer during chemo therapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026