RecruitingPhase 2Phase 3NCT04715958

SHAPE Neoadjuvant Chemotherapy Response

Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

Sponsor

Kibo Nam

Enrollment

200 participants

Start Date

Dec 7, 2020

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage III Breast Cancer AJCC v8 Locally Advanced Breast Carcinoma

Summary

This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a special type of ultrasound using a contrast dye can predict how well breast cancer will respond to chemotherapy given before surgery. It is intended for women with locally advanced breast cancer who are scheduled for chemotherapy before an operation. **You may be eligible if:** - You are a woman at least 21 years old - You have been diagnosed with breast cancer (stage T1 or higher) and are scheduled for chemotherapy before surgery - You are medically stable and able to follow study procedures - You are not pregnant **You may NOT be eligible if:** - You are male - You are pregnant or breastfeeding - You have another active cancer requiring treatment - You have cancer that has spread to distant parts of the body - You are receiving hormone therapy instead of chemotherapy before surgery - You have a known allergy to the ultrasound contrast agent (Definity) - You have severe heart or lung conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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