Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

NCT02891681 | Completed Results DMC FDA Device

• 2 other identifiers: 2016081017R01EB002136-12
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Tumors; Cancer of Breast; Cancer of the Breast; Malignant Neoplasm of Breast

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 6 months

Study Arms (2)

NIR/US (Neoadjuvant Chemotherapy Cohort)

EXPERIMENTAL

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

NIR/US (Neoadjuvant Endocrine Cohort)

EXPERIMENTAL

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

Interventions

Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound DEVICE

Also known as: NIR/US

NIR/US (Neoadjuvant Chemotherapy Cohort); NIR/US (Neoadjuvant Endocrine Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and/or breastfeeding
• Prior history of breast cancer
• Prior history of chest wall radiation
• Prior history of breast reconstruction, reduction, or augmentation

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 33970392 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Quing Zhu, Ph.D.
• Organization: Washington University School of Medicine

zhu.q@wustl.edu

314-935-7519

Study Officials

• Quing Zhu, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: November 29, 2016
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)