Evaluating Optical Spectroscopy for Monitoring Breast Cancer Treatment Responses

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

This study is testing a new light-based method to see if it can help track how well treatment is working for women with locally advanced breast cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 20 Years to 80 Years
• Sex: Female
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT00438074 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effectiveness of pulsed time-domain optical spectroscopy in monitoring the responses of women with locally advanced breast cancer undergoing neoadjuvant treatments. The study aims to identify optical tissue characteristics that change with treatment and correlate with pathological responses. By utilizing diffuse optical spectroscopy, the researchers hope to establish early predictors of treatment outcomes, potentially improving patient management and treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20 to 80 with locally advanced breast cancer who are receiving neoadjuvant chemotherapy or radiation therapy.

Not a fit: Patients with a history of significant medical conditions or surgical procedures that may interfere with the study's assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to predict treatment responses in breast cancer patients, leading to more personalized treatment plans.

How similar studies have performed: While the use of optical spectroscopy in cancer monitoring is an emerging field, similar studies have shown promise in utilizing imaging methods for treatment response evaluation.

Eligibility criteria

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.

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Gregory J. Czarnota, Ph.D. M.D. — Sunnybrook Health Sciences Centre
• Study coordinator: Gregory J Czarnota

Conditions: Breast Cancer, Diffuse Optical Spectroscopy