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

Breast Cancer Clinical Trial

Official title:

Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134780
• Other study ID #: 301-2014
• Status: Recruiting
• Start date: August 2014
• Est. completion date: October 2029

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Gregory J Czarnota, PhD, MD
• Phone: (416) 480-6128
• Email: gregory.czarnota[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 advanced breast cancer receiving treatment with chemotherapy or combined modality chemotherapy and radiotherapy. A secondary objective is to perform an inter-user variability comparison by comparing second site data analysis outcomes with central co-coordinating site data analysis. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound, which is non-invasive, inexpensive and portable to assess breast cancer therapies through functional imaging, in which tumour cell death is detected. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. This has the potential of improving survival in addition to sparing patients unnecessary side effects of treatments that may span weeks to months. The investigators will use these quantitative methods to evaluate treatments with neoadjuvant chemotherapy in women with locally advanced breast cancer. This investigation will track the spatio-temporal changes in quantitative ultrasound surrogates of treatment response during neoadjuvant chemotherapy of locally advanced breast cancer and use these parameters to adapt clinical treatment. The study specifically will expand on single- institution research underway and involve a second clinical site. Data will be independently collected and analysis carried out at that site and at the co-ordinating site for comparison evaluating technology-use feasibility and reproducibility of results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2029
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment

3. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1

4. Life expectancy of at least 6 months

5. 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 Criteria:

1. History of allergic reactions attributed to compounds of similar chemical or biologic composition

2. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia

3. Psychiatric illness/social situations that would limit compliance with study requirements

4. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	MD Anderson	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-user variability comparison	Comparing second site data analysis outcomes with central co-coordinating site data analysis	Up to 5 years