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

NCT04134780 | Recruiting

• 1 other identifier: 301-2014
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

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 way of monitoring early response to cancer treatment and predicting which patients continue on in their therapy to have a complete pathological response as a primary endpoint and tumour size decrease as a secondary endpoint. If this work is successful it could be used in the future early on in a cancer patient's treatment to predict whether or not a course of chemotherapy or radiotherapy is going to be successful. For example, in patients in which the analysis indicates a poor response the chemotherapy regimen could be changed to a more efficacious one or for those receiving radiotherapy predicted to have a poor response a radiosensitizing agent could be used to improve outcome.

Conditions

Breast Cancer

Keywords

Ultrasound; Spectroscopy; Characterization

Outcome Measures

Primary Outcomes (1)

• Measuring the rate of treatment response between the treatment groups

  Correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete or partial response

  Up to 5 years

Secondary Outcomes (1)

• Inter-user variability comparison

  Up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both men and women and members of all races and ethnic groups are eligible for this trial.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

MD Anderson

Houston, Texas, 77030, United States

COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

COMPLETED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416) 480-6128; gregory.czarnota@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinician Scientist

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: August 1, 2014
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (1); CA (2)