Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy
Response Using Diffuse Optical Spectroscopic Imaging (DOSI)


Principal Investigator: Bruce J. Tromberg, PhD

Status: Open

Main Objective: DOSI will be used to evaluate the patient’s response
to chemotherapy. The primary aim of this clinical trial is to determine whether
the baseline to mid-therapy changes in the DOSI measurement of the quantitative
tumor tissue optical index (TOI) can predict final complete pathologic response in
breast cancer patients undergoing pre-surgical neoadjuvant chemotherapy. The
secondary aims investigate the correlation between additional DOSI quantitative
measurements of tumor biochemical composition obtained at other timepoints,
the full range of pathologic response (i.e. complete, partial, and non-response)
and any corresponding imaging measurements. DOSI and standard of care
imaging (e.g. serial mammograms, serial ultrasounds, etc) and/or all MRI (e.g.,
SOC imaging or MRI imaging from co-enrollment in ACRIN 6657 or other studies)
will be collected.

Participants: Patients who have been diagnosed with breast cancer, have had
disease confirmation by initial treatment biopsy, and are scheduled to receive
neoadjuvant chemotherapy followed by surgery are eligible for this trial.

Limited Site Participation
This is a limited participation study. The study is a joint effort between ACRIN and the
NCI Network for Translational Research of the Interdisciplinary (NTROI) Research Consortium.
All sites will use NTROI standardized DOSI specifications and procedures, SOC and/or other
MRI imaging, and standard-of-care histopathology to assess pathological response. A total of
five NTROI clinical sites with identical DOSI instruments and procedures will participate:
University of California, Irvine, University of California, San Francisco, University of Pennsylvania,
Dartmouth, and Harvard/Massachusetts General Hospital.