Who is eligible for clinical trial NCT06193122?

Participants must meet the protocol's inclusion criteria for Breast Cancer. Confirm all requirements with the study coordinator.

Does clinical trial NCT06193122 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

Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment (NCT06193122)

Investigation of Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Sunnybrook Health Sciences Centre

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

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 chemotherapy or concurrent chemotherapy-radiotherapy. The main goal is to select the best ultrasound spectroscopy parameter and vascular-distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint and tumour size decrease as a secondary endpoint.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (12 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

🧪 Interventions in This Study

Ultrasound imaging 3D and Spectroscopy (DEVICE)

📋 "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).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 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

📞 Contact the Study Coordinator

Phone: (416) 480-5329

Email: Gregory.Czarnota@sunnybrook.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗