Using ultrasound imaging to predict breast cancer treatment response

Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

This study tests if different types of ultrasound imaging can help predict how well breast cancer patients respond to their chemotherapy and radiotherapy treatments.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Sex: Female
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT00437879 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed breast carcinoma, stages I-IV, who have not yet received first-line therapy and are scheduled for neoadjuvant chemotherapy or combined chemo-radiotherapy.

Not a fit: Patients with previously treated breast cancer or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to predict how well patients will respond to breast cancer treatments, potentially leading to more personalized treatment plans.

How similar studies have performed: Other studies have shown promise in using ultrasound imaging for treatment response evaluation, but this specific approach is relatively novel.

Eligibility criteria

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 this trial is running

Toronto, Ontario

• 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

Conditions Breast Cancer Invasive; Breast Cancer; Ultrasound; Neoadjuvant Treatment