Status:
NOT_YET_RECRUITING
Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Breast Cancer
Eligibility:
All Genders
Brief Summary
The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to neoadjuvant treatment consisting of chemot...
Detailed Description
This project is an early validation study in human subjects that will use three-dimensional ultrasound imaging and spectroscopy to monitor cell death occurring at various time points during a patient'...
Eligibility Criteria
Inclusion
- 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.
- Disease must be measurable 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.
Exclusion
- 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.
- Known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition.
- Contraindications to radiotherapy such as but not limited to:
- (i) previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity.
- Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- History of active ongoing seizure disorder.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06193122
Start Date
April 1 2024
End Date
April 1 2029
Last Update
January 5 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5