Who is eligible for clinical trial NCT04050228?

Participants must meet protocol criteria for Breast Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04050228 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2023-12-20

Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer (NCT04050228)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (9 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Women ≥ 18 years of age
Diagnosis of breast cancer with a primary tumour \>2cm in size
With conditions meeting criteria for chemotherapy administration
Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
Creatinine ≤175 µmol/L
Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
Cardiac function (left ventricular ejection fraction) ≥55%
Eligible for neoadjuvant chemotherapy.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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
No peripheral neuropathy of a severity of grade ≥2
Evidence of distant metastatic disease
Known sensitivity to components present in ultrasound gel.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Sunnybrook Health Sciences Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗