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Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

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ClinicalTrials.gov Identifier: NCT02891681
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : February 18, 2019
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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

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


Contacts
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Contact: Steven Poplack, M.D. 314-454-7405 poplack@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Steven Poplack, M.D.    314-454-7405    poplack@wustl.edu   
Principal Investigator: Steven Poplack, M.D.         
Sub-Investigator: Quing Zhu, M.D.         
Sub-Investigator: Foluso Ademuyiwa, M.D.         
Sub-Investigator: Cynthia Ma, M.D., Ph.D.         
Sub-Investigator: Catherine Appleton, M.D.         
Sub-Investigator: Souzan Sanati, M.D.         
Sub-Investigator: Ron Bose, M.D., Ph.D.         
Sub-Investigator: Matthew Cherian, M.D.         
Sub-Investigator: Ashley Firth, M.D.         
Sub-Investigator: Leonel Hernandez Aya, M.D.         
Sub-Investigator: Michael Naughton, M.D.         
Sub-Investigator: Haeseong Park, M.D.         
Sub-Investigator: Antonella Rastelli, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Catherine Young, M.D.         
Sub-Investigator: Lindsay Peterson, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Steven Poplack, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02891681     History of Changes
Other Study ID Numbers: 201608101
7R01EB002136-12 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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