A Pilot Study To Evaluate the Effectiveness of Pulsed Time-Domain Optical Spectroscopy for Monitoring the Responses in Neoadjuvant Treatments of Locally-Advanced Breast Cancer
Breast cancer is the most common malignancy for females in North America. Around 5-15% of
the estimated 200,000 new cases diagnosed each year will present with locally advanced
breast cancer (LABC) (The definition of what constitutes "LABC" is complex and variable.
Clinically these tumours are usually considered to be those greater than 5cm in size and/or
extend beyond the breast tissue into the surrounding skin or muscle. Patients with matted
axillary lymph nodes (N2) or internal mammary nodes (N3) or ipsilateral supraclavicular
lymph node involvement are also considered to have LABC. In view of the extensive nature of
these tumours at presentation, women with LABC have a poor outcome in terms of both local
and systemic recurrence. Standard treatment for these patients is usually neoadjuvant
systemic (chemotherapy or less frequently endocrine therapy) followed by surgery and
radiotherapy. Patients who have hormone receptor positive tumours will then receive
endocrine therapy. With the use of multidisciplinary therapy, 10-year disease free survival
rates of 50% for Stage IIIA and 33% for Stage IIIB disease have been reported.
The impetus for undertaking this study is that we are searching for imaging methods that
could potentially serve as surrogate indicators of pathological response. One such modality
that we wish to investigate as it may be ultimately useful in this patient population is
diffuse optical spectrometry. This modality depends on differentiating oxygenated from
deoxygenated tissue but is also sensitive to other changes in tissue characteristics. It has
been used before in proof-of-principle studies differentiating benign from malignant disease
but we hypothesize that it may be more useful in terms of monitoring tumour responses to
treatment. This is a non-invasive imaging modality that is easy to administer and relatively
inexpensive.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Gregory J. Czarnota, Ph.D. M.D.
Principal Investigator
Sunnybrook Health Sciences Centre
Canada: Ethics Review Committee
186-2006
NCT00438074
February 2007
September 2013
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