Actively Recruiting
SHAPE Neoadjuvant Chemotherapy Response
Led by Kibo Nam · Updated on 2026-04-06
200
Participants Needed
3
Research Sites
307 weeks
Total Duration
On this page
Sponsors
K
Kibo Nam
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SHAPE Neoadjuvant Chemotherapy Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- At least 21 years old
- Diagnosed with breast cancer (T1 or greater locally advanced breast cancer, any lymph node involvement, no distant metastasis)
- Scheduled to receive neoadjuvant chemotherapy
- Medically stable
- Conscious and able to comply with study procedures
- If female of child-bearing potential, must have a negative urine pregnancy test
You will not qualify if you...
- Male gender
- Pregnant or nursing females
- Patients with other primary cancers requiring systemic treatment
- Patients with distant metastatic disease
- Patients undergoing neoadjuvant endocrine therapy
- Medically unstable patients, seriously or terminally ill, or with unpredictable clinical course
- Patients on life support or in critical care
- Patients with unstable occlusive disease (e.g., crescendo angina)
- Patients with unstable cardiac arrhythmias like recurrent ventricular tachycardia
- Patients with uncontrolled congestive heart failure (NYHA Class IV)
- Patients with recent cerebral hemorrhage
- Patients who had surgery within 24 hours prior to study ultrasound
- Known allergy to any Definity component
- Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
- Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension, or history of pulmonary emboli
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
3
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
K
Kibo Nam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here