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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02891681
Other study ID # 201608101
Secondary ID 7R01EB002136-12
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2016
Est. completion date January 23, 2020

Study information

Verified date January 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound


Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

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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