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Completed

NCT Number: NCT02891681

Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Tumors Cancer of Breast Cancer of the Breast Malignant Neoplasm of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound

Device

Other names: NIR/US

Primary outcomes

  1. Pathologic Response Based on Miller-Payne Grading System

    Time frame: Up to 6 months

    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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2016
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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