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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00438074
Recruitment Status : Recruiting
First Posted : February 21, 2007
Last Update Posted : September 19, 2019
ART Advanced Research Technologies Inc.
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

Brief Summary:
This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. The ultimate goal is to use such parameters ultrasound as an early predictor of pathological partial or complete response in women with locally advanced breast cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant combined modality chemotherapy and radiotherapy.

Condition or disease
Breast Cancer

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : February 2007
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for locally-advanced breast cancer.

Inclusion Criteria:

  • Locally Advance Breast Cancer
  • Subjects must give appropriate written informed consent prior to participation in the study;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00438074

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Contact: Gregory J Czarnota 416-480-5329

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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Gregory J. Czarnota, Ph.D. M.D.         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
ART Advanced Research Technologies Inc.
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Principal Investigator: Gregory J. Czarnota, Ph.D. M.D. Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Gregory Czarnota, Dr., Sunnybrook Health Sciences Centre Identifier: NCT00438074    
Other Study ID Numbers: 186-2006
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre:
Breast Cancer
Diffuse Optical Spectroscopy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases