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Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891681
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Tumors Cancer of Breast Cancer of the Breast Malignant Neoplasm of Breast Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: NIR/US




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891681


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Qing Zhu, Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02891681    
Other Study ID Numbers: 201608101
7R01EB002136-12 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases