- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04715958
Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Study Overview
Status
Conditions
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Locally Advanced Breast Carcinoma
Intervention / Treatment
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 breast cancer.
SECONDARY OBJECTIVE:
I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.
OUTLINE:
Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (IV) over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC.
After completion of study, patients are followed up at the completion of NAC.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University Hospital
-
Contact:
- Kibo Nam, PhD
- Phone Number: 215-955-6261
- Email: Kibo.Nam@jefferson.edu
-
Principal Investigator:
- Kibo Nam, PhD
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Basak Dogan
- Phone Number: 214-645-9729
- Email: Basak.dogan@utsouthwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC
|
Undergo CEUS
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
Time Frame: Up to study completion (48 months)
|
3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC.
The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.
|
Up to study completion (48 months)
|
Prediction of the patients' clinical and pathological response
Time Frame: Up to study completion (48 months)
|
The SHAPE results from three time points (i.e.
before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling.
|
Up to study completion (48 months)
|
The ability of the SHAPE method to distinguish responders from non-responders
Time Frame: Up to study completion (48 months)
|
Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity.
|
Up to study completion (48 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype
Time Frame: Up to study completion (48 months)
|
The variation of the accuracies of the SHAPE results by breast cancer subtypes will be reported.
The generalized linear mixed effects or GEE modeling will be stratified by breast cancer subtype and also extended to include modeling of breast cancer subtype as a main effect and as an interaction effect with SHAPE.
|
Up to study completion (48 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20F.259
- R37CA234428 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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