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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

20 Years
80 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Inclusion Criteria:

- Locally Advance Breast Cancer

- Subjects must give appropriate written informed consent prior to participation in the

- Subjects must be able and willing to comply with the safety procedures during the
Scanning Period;

- Subjects must be women of between 20 and 80 years of age, inclusive, on the day the
Informed Consent Form is signed;

- Subjects must be women who will be receiving neoadjuvant radiation therapy and/or
chemotherapy for locally-advanced breast cancer.

- Subjects of childbearing potential must be using an acceptable method of birth
control. Subjects not of childbearing potential are defined as either surgically
sterile or post-menopausal. Post-menopausal women are defined as those women with a
documented menstruation cessation for 12 consecutive months prior to signing the
Informed Consent Form

Exclusion Criteria:

- Subjects with a past medical history of abnormalities, significant injury, or medical
or surgical procedures (e.g.,silicone/saline implants) involving either breast,
exclusive of the lesion at issue;

- Subjects with any dermatologic abnormalities (including tattoos, open sores, or
breached skin) involving either breast;

- Subjects with a current or past medical history of connective tissue disease;

- Subjects who are pregnant or lactating;

- Subjects with an implanted electronic device such as a cardiac pacemaker,
defibrillator, or neurological stimulator;

- Subjects with a history or expectation of significant anxiety associated with
undergoing diagnostic evaluations;

- Subjects with a history of musculoskeletal disease which may predispose them to
discomfort during the Scanning Period;

- Subjects with a known sensitivity to purified water, soybean oil, sucrose,
polysorbate 80, oleic acid, EDTA, benzalkonium chloride, FD&C caramel color,
butylated hydroxyanisole, and/or sodium hydroxide;

- Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result
of a dermatologic condition); and

- Subjects, who, in the opinion of the investigator or clinical research coordinator,
may not otherwise be appropriate for inclusion into the study.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Gregory J. Czarnota, Ph.D. M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre


Canada: Ethics Review Committee

Study ID:




Start Date:

February 2007

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Diffuse Optical Spectroscopy
  • Breast Neoplasms