Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

Study Overview
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Brief Summary
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To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.

Official Title
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Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

Conditions
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Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Malignant Neoplasm of Breast

Intervention / Treatment
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* Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort) At least 18 years of age Female Able to understand and willing to sign an IRB-approved written informed consent document Exclusion Criteria: Pregnant and/or breastfeeding Prior history of breast cancer Prior history of chest wall radiation Prior history of breast reconstruction, reduction, or augmentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIR/US (Neoadjuvant Chemotherapy Cohort)<br>Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response. In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery. The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen | Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound<br> <br> * Other names: NIR/US;|
| Experimental: NIR/US (Neoadjuvant Endocrine Cohort)<br>Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response. In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery. The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen | Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound<br> <br> * Other names: NIR/US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Response Based on Miller-Payne Grading System | In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as: grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR) grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR) grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR) grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present) | Up to 6 months |