Status:

RECRUITING

Ultrasound Imaging and Spectroscopy as Early Indicators of Locally-Advanced Breast Cancer Response

Lead Sponsor:

Sunnybrook Health Sciences Centre

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Brief Summary

This work explores the possibility of using ultrasound imaging and spectroscopy as a way of monitoring cell death, hence, tumour response to treatment. The hypothesis here is that it can be used as a ...

Detailed Description

The primary objective in this study is to identify optimal ultrasound spectroscopy parameters that can be used as an early predictor of pathological complete or partial response in women with locally ...

Eligibility Criteria

Inclusion

  • Histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
  • Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
  • Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 6 months
  • Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures

Exclusion

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Key Trial Info

Start Date :

August 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2029

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT04134780

Start Date

August 1 2014

End Date

October 1 2029

Last Update

December 14 2023

Active Locations (3)

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Page 1 of 1 (3 locations)

1

MD Anderson

Houston, Texas, United States, 77030

2

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

3

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9