Ultrasound Scans for Early Signs of Breast Cancer Response to Pre-Surgery Treatment
Studies whether ultrasound scans can detect early response in women with invasive breast cancer.
Key facts
- Who runs it
- Sunnybrook Health Sciences Centre
- Where
- Toronto, CanadaSee the site
- Trial code
- Registry title
- Ultrasound Imaging, Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment.
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 17 Dec 2008
- Expected to end
- Jun 2029
- Type of study
- Observational
- Record updated
- 12 December 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with breast cancer who have not yet had first-line treatment and will have chemotherapy or chemo-radiotherapy before surgery. It tests ultrasound imaging as an early sign of response.
- Sex
- Women only.
- Disease stage
- Breast carcinoma confirmed by tissue or cell testing, stage I-IV, measurable on ultrasound or MRI done within 28 days before treatment.
- Earlier treatment
- No first-line therapy before. No chemotherapy, radiotherapy or major surgery within 4 weeks before joining.
Main reasons for not taking part
- Receiving any other investigational agents
- Known brain metastases
- Past allergic reactions to similar compounds
- Not recovered from side effects of treatment given more than 4 weeks before registration
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- The following criteria are necessary for study participation:
- 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
- Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 6 months
- 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
- 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
Who cannot take part
- 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
- Receiving any other investigational agents
- The following conditions will exclude women from participation:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition
- Known brain metastases
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Gregory J. CzarnotaTaking people
About the trial
What the trial wants to find out
We 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. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
Read full original descriptionShow less
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
- Plain-language title
- Ultrasound Scans for Early Signs of Breast Cancer Response to Pre-Surgery TreatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 December 2023