Recruiting

Pulsed Time-Domain Optical Spectroscopy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT00438074

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT00438074

Start date

Feb, 2007

Status verified date

Feb, 2024

Completion date

May 17, 2024

Anticipated

Primary completion date

May 17, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Gregory J Czarnota

416-480-5329gregory.czarnota@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator:

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Feb 9, 2024

Last verified

Feb, 2024

Keywords

  • Breast Cancer
  • Diffuse Optical Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-02-09.