Breast Cancer Clinical Trial
Official title:
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Verified date | January 2021 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 23, 2020 |
Est. primary completion date | January 23, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | National Institute for Biomedical Imaging and Bioengineering (NIBIB) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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