Status:
RECRUITING
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
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
ART Advanced Research Technologies Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-80 years
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 para...
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) (T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 17 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00438074
Start Date
February 1 2007
End Date
May 17 2024
Last Update
February 9 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5