Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

The Washington University

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02891681

7R01EB002136-12 (U.S. NIH Grant/Contract)

201608101

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

NIR/US (Neoadjuvant Chemotherapy Cohort)

Experimental group

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

Treatment:

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

NIR/US (Neoadjuvant Endocrine Cohort)

Experimental group

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

Treatment:

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