RecruitingNot ApplicableNCT04050228

Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

240 participants

Start Date

Jun 13, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. 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. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using quantitative ultrasound — a special way of analyzing ultrasound images that gives numerical data about tissue — can monitor how a breast tumor is responding to chemotherapy and guide treatment decisions in real time. The goal is to personalize chemotherapy for women with breast cancer. **You may be eligible if...** - You are a woman 18 or older with a breast cancer tumor larger than 2 cm - You are scheduled for chemotherapy before surgery (neoadjuvant chemotherapy) - Your blood counts, kidney, and liver function are within acceptable ranges - Your heart function (ejection fraction) is 55% or higher **You may NOT be eligible if...** - You have inflammatory breast cancer - You are pregnant or breastfeeding - You have a connective tissue disease or skin condition affecting the breast - Your cancer has already spread to distant organs (metastatic disease) - You have significant nerve damage (peripheral neuropathy grade 2 or higher) - You have an allergy to ultrasound gel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEQuantitative ultrasound to guide adaptive chemotherapy

Quantitative ultrasound results will be used to measure chemotherapy response and guide an adaptive chemotherapy strategy for patients who are found to be nonresponders to their chemotherapy.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT04050228


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