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).
Women ≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
Inflammatory breast cancer
Prior breast cancer requiring surgery or radiation in either breast
Pregnant or nursing due to changes in breast architecture
Single group
NearWave monitoring
DeviceNearWave optical molecular monitoring
Feasibility 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;
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
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.
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Indiana University
Lead sponsor
University of Notre Dame
Collaborator
Elevate Ventures
Collaborator
NearWave Corp.
Collaborator
