ACRIN PROTOCOL 6691 Minimize

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

Principal Investigator: Bruce J. Tromberg, PhD

Status: In Follow-up

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.

Participants: Women are eligible for this trial if they have been diagnosed with breast cancer
by clinical breast examination, standard-of-care diagnostic imaging, or initial tissue biopsy
(confirmed by local site pathologist), and are scheduled to receive neoadjuvant chemotherapy
followed by surgery.

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, standard-of-care and/or other MRI imaging,
and standard-of-care histopathology to assess pathological response. A total of seven NTROI clinical
sites with identical DOSI instruments and procedures will participate: University of California, Irvine,
University of California, San Francisco, University of Pennsylvania, Dartmouth, Harvard/Massachusetts
General Hospital, Boston University, and M. D. Anderson Cancer Center.