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Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

Primary Purpose

Breast Cancer, Breast Tumors, Cancer of Breast

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NIR/US (Neoadjuvant Chemotherapy Cohort)

NIR/US (Neoadjuvant Endocrine Cohort)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 31, 2016
Last Updated
January 28, 2021
Sponsor
Washington University School of Medicine
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT02891681
Brief Title
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Official Title
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Malignant Neoplasm of Breast

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIR/US (Neoadjuvant Chemotherapy Cohort)
Arm Type
Experimental
Arm Description
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
Arm Title
NIR/US (Neoadjuvant Endocrine Cohort)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
Other Intervention Name(s)
NIR/US
Primary Outcome Measure Information:
Title
Pathologic Response Based on Miller-Payne Grading System
Description
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)
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quing Zhu, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33970392
Citation
Zhu Q, Ademuyiwa FO, Young C, Appleton C, Covington MF, Ma C, Sanati S, Hagemann IS, Mostafa A, Uddin KMS, Grigsby I, Frith AE, Hernandez-Aya LF, Poplack SS. Early Assessment Window for Predicting Breast Cancer Neoadjuvant Therapy using Biomarkers, Ultrasound, and Diffuse Optical Tomography. Breast Cancer Res Treat. 2021 Aug;188(3):615-630. doi: 10.1007/s10549-021-06239-y. Epub 2021 May 10.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

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