Using ultrasound and spectroscopy to monitor breast cancer treatment response

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

This study is testing if ultrasound and spectroscopy can help doctors see how well breast cancer treatments are working for patients sooner, so they can make changes if needed.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Houston, Texas and 2 other locations)
• Trial ID: NCT04134780 on ClinicalTrials.gov

What this trial studies

This study investigates the use of ultrasound imaging and spectroscopy to monitor cell death in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy or combined chemo-radiotherapy. The primary goal is to identify ultrasound parameters that can predict early treatment responses, allowing for timely adjustments to therapy if necessary. By detecting treatment efficacy within days rather than weeks, this approach aims to improve patient outcomes and reduce unnecessary side effects. The study also includes an analysis of inter-user variability in data interpretation to ensure consistency in results.

Who should consider this trial

Good fit: Ideal candidates are women with histologically confirmed locally advanced breast cancer who have not yet received first-line therapy.

Not a fit: Patients with uncontrolled intercurrent illnesses or those who have previously received treatment for their breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for breast cancer patients, improving survival rates.

How similar studies have performed: While the use of ultrasound in cancer treatment monitoring is established, this specific application of spectroscopy as an early predictor is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Houston, Texas and 2 other locations

• MD Anderson — Houston, Texas, United States (Completed)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Completed)

Study contacts

• Principal investigator: Gregory Czarnota, PhD, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Gregory J Czarnota, PhD, MD

Conditions Breast Cancer; Ultrasound; Spectroscopy; Characterization