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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

NCT01257932

Breast Cancer

WITHDRAWN

Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

NCT02725658

Breast Tumor

WITHDRAWN NA

Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

NCT00540852

Breast Cancer

COMPLETED NA

Monitoring and Predicting Chemotherapy Response Using DOSI

NCT01217385

Breast Cancer

COMPLETED NA

Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging

NCT02510456

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diffuse Optical Spectroscopy Imaging

Monitoring Breast Cancer during chemo therapy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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