Using ultrasound imaging to predict breast cancer treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of high-frequency and conventional-frequency ultrasound imaging and spectroscopy as predictive markers for breast cancer response to neoadjuvant chemotherapy and radiotherapy. It aims to correlate changes in ultrasound parameters with pathological responses in patients undergoing treatment. Additionally, the study investigates the impact of neoadjuvant therapies on tumor vasculature using advanced imaging techniques. The ultimate goal is to identify the best ultrasound spectroscopy parameters for early prediction of treatment outcomes.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

The following criteria are necessary for study participation:

1. Histologically or cytologically confirmed breast carcinoma, stage I-IV, 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. Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing:

   (i) hemoglobin \>90 mg/dL (ii) leukocytes \>3,000/mL (iii) absolute neutrophil count \>1,500/mL (iv) platelets \>100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
6. 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

The following conditions will exclude women from participation:

1. Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
2. Receiving any other investigational agents.
3. Known brain metastases.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition.

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Gregory J. Czarnota, Ph.D. M.D. — Sunnybrook Health Sciences Centre
• Study coordinator: Gregory J. Czarnota
• Email: Gregory.Czarnota@sunnybrook.ca
• Phone: 416-480-5329

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.