Actively Recruiting
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2023-12-28
240
Participants Needed
1
Research Sites
572 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Diagnosis of breast cancer with a primary tumor larger than 2 cm
- Conditions meeting criteria for chemotherapy administration
- Normal blood counts (hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10^9, absolute neutrophil count ≥ 2.0 x 10^9 cells/L)
- Creatinine level ≤ 175 µmol/L
- Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
- Cardiac function with left ventricular ejection fraction ≥ 55%
- Eligible for neoadjuvant chemotherapy
You will not qualify if you...
- Inflammatory breast cancer
- Contraindications to neoadjuvant treatment, including pregnancy or lactation
- Past medical history of connective tissue disease
- Past history of dermatologic disease involving the breast
- Eastern Cooperative Group Status (ECOG) 3 or higher
- Peripheral neuropathy of grade 2 severity or higher
- Evidence of distant metastatic disease
- Known sensitivity to components in ultrasound gel
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
G
Gregory J Czarnota, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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