Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)
- To determine whether the percentage change in the diffuse optical spectroscopy imaging
(DOSI) measurement of the tumor/normal (T/N) tissue optical index (TOI) from baseline
to mid-therapy is predictive of the final pathologic response of the primary tumor in
patients with locally advanced breast cancer treated with neoadjuvant chemotherapy.
- To investigate whether change of TOI measurements from baseline to post-therapy are
predictive of the final pathologic response in these patients treated with this
- To investigate whether baseline TOI measurements are associated with final pathologic
response in patients treated with this regimen.
- To investigate whether TOI measurements at baseline, change from baseline to
mid-therapy, and change from baseline to post-therapy correlate with available MRI
volumetric imaging measurements.
- To investigate whether changes on TOI measurements from baseline to mid-therapy, and
from baseline to post-therapy, correlate with other standard-of-care imaging and/or any
- To explore whether additional optical endpoints and indices obtained during DOSI
measurements can be used to predict final pathologic response in patients treated with
- To determine a cutpoint for the percent change of TOI from baseline to mid-therapy that
is predictive of pathological complete response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo diffuse optical spectroscopy imaging (DOSI) at baseline, 5-10 days after
initiation of neoadjuvant chemotherapy, during early- and mid-neoadjuvant therapy, and
within 21 days after completion of neoadjuvant therapy. Results are compared to
standard-of-care imaging (e.g., MRI, ultrasound, mammography). Patients then undergo
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Relationship between pathological complete response and percent change from baseline to post-therapy in tissue optical index (TOI) tumor to normal ratio
Bruce J. Tromberg, MD
Chao Family Comprehensive Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|