The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).
This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study. Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
NearWave optical molecular monitoring
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGFeasibility of using NearWave imaging as a monitoring system
Adequate data quality metrics: Signal-to-noise ratio (SNR) (measurement that compares the strength of a signal to the level of background noise) above 10 dB for at least 80% of collected data points;
Time frame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
Feasibility of using NearWave imaging as a monitoring system
Adequate data quality metrics: • Model fit metric: Root mean squared error (RMSE) ( the average difference between the predicted values and the actual values) of 5x10-4 or lower for regressions of calibrated imaging
Time frame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
Feasibility of using NearWave imaging as a monitoring system
Adequate data quality metrics: • Estimated tissue concentrations of HHb, HbO2, water, and lipid within expected physiological ranges.
Time frame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
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