Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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

Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound

Quing Zhu, Ph.D.

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.

Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

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)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Washington University School of Medicine

Adverse events were not collected for this study. If a serious adverse event was suspected to be caused by the NIR/US scan then it was collected and reported.

NIR/US (Neoadjuvant Chemotherapy Cohort)

NIR/US (Neoadjuvant Endocrine Cohort)

NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

For this outcome measure, the one participant who was in the crossover cohort was counted in the neoadjuvant chemotherapy cohort. Three participants in the neoadjuvant chemotherapy cohort were not evaluable for this outcome measure (2 developed metastases prior to completing neoadjuvant therapy and 1 was taken off study after first imaging appointment).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment	NCT02891681	Breast Cancer Breast Tumors Cancer of Breas... Cancer of the B... Malignant Neopl...	Optical Tomogra...	18 Years -	Washington University School of Medicine
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment	NCT02891681	Breast Cancer Breast Tumors Cancer of Breas... Cancer of the B... Malignant Neopl...	Optical Tomogra...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for optical tomography using near infrared diffused light assisted with ultrasound