Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

January 28, 2021 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR/US (Neoadjuvant Chemotherapy Cohort)

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
Other Names:
  • NIR/US
Experimental: NIR/US (Neoadjuvant Endocrine Cohort)

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
Other Names:
  • NIR/US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Quing Zhu, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201608101
  • 7R01EB002136-12 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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