Status:
RECRUITING
Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer
Lead Sponsor:
Kibo Nam
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Breast Carcinoma
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with b...
Eligibility Criteria
Inclusion
- 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
- Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
- Be scheduled for neoadjuvant chemotherapy
- Be medically stable
- Be conscious and able to comply with study procedures
- If a female of child-bearing potential, must have a negative urine pregnancy test
Exclusion
- Males
- Females who are pregnant or nursing
- Patients with other primary cancers requiring systemic treatment
- Patients with any distal metastatic disease
- Patients undergoing neoadjuvant endocrine therapy
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit;
- Patients with unstable occlusive disease (e.g., crescendo angina);
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
- Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class IV);
- Patients with recent cerebral hemorrhage;
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- Patients with known hypersensitivity or allergy to any component of Definity
- Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
- Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04715958
Start Date
December 7 2020
End Date
May 31 2026
Last Update
April 29 2025
Active Locations (3)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
3
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390