Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

Breast Cancer Clinical Trial

Official title:

Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891681
• Other study ID #: 201608101
• Secondary ID: 7R01EB002136-12
• Status: Completed
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: January 23, 2020

Study information

• Verified date: January 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Tumors
• Cancer of Breast
• Cancer of the Breast
• Malignant Neoplasm of Breast
• Neoplasms

Intervention

Device:
• Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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