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

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ClinicalTrials.gov Identifier: NCT04715958
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Kibo Nam, Thomas Jefferson University

Study Description
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Brief Summary:
This phase II/III trial studies if contrast-enhanced ultrasound (CEUS) using a contrast agent, perflutren lipid microspheres (Definity), can predict the early response of breast cancer to neoadjuvant chemotherapy by estimating the pressure gradient between the breast cancer and surrounding tissues. To estimate the pressures noninvasively, subharmonic (half of fundamental frequency) aided pressure estimation (SHAPE) using CEUS will be utilized. The study hypothesis is that the subharmonic signal difference in the tumor relative to the normal tissue can predict breast cancer NAC response after 10% of therapy regimen.

Condition or disease Intervention/treatment Phase
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 Locally Advanced Breast Carcinoma 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 Procedure: Contrast-Enhanced Ultrasound Drug: Perflutren Lipid Microspheres Phase 2 Phase 3

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 NAC response varies with breast cancer subtype.

OUTLINE:

Patients undergo contrast-enhanced ultrasound (CEUS) with Definity (perflutren lipid microspheres) intravenously (IV) over 10-15 minutes before NAC, after 10% (1-2 cycles) of NAC, and after 30% (2-4 cycles) of NAC.

After completion of study, patients are followed up at the completion of NAC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Perflutren

Arms and Interventions
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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
 Procedure: Contrast-Enhanced Ultrasound
Undergo CEUS
Other Name: CEUS

Drug: Perflutren Lipid Microspheres
Given IV
Other Name: Definity


Outcome Measures
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Primary Outcome Measures :
  1. Prediction of the patients' clinical and pathological response [ Time Frame: Up to study completion (48 months) ]
    The SHAPE results from three time points will be compared to the patients' clinical response as well as pathological response. The imaging response outcome will be determined by the tumor size reduction percentage. We will use a threshold value of 90% to differentiate the responders from partial/non-responders. MRI baseline images before and after the completion of the NAC will be acquired if available. If a patient's MRIs are not available, 3D measurements from ultrasound images will be utilized. A subject who drops out of the study during the therapy, due to the progression of disease, will be considered as a non-responder. The pathologic response will be evaluated with a 5-point grading scale: no therapeutic effect (grade 1), minimal therapeutic effect (grade 2), moderated therapeutic effect with invasive tumor or vascular invasion (grade 3), marked therapeutic effect with no/minimal invasive tumor (grade 4), or complete therapeutic effect with no invasive disease (grade 5).


Secondary Outcome Measures :
  1. Comparison of prediction accuracy of SHAPE based on breast cancer subtype [ Time Frame: Up to study completion (48 months) ]
    The accuracy of SHAPE to predict the patients' clinical and pathological outcomes will be compared among breast cancer subtypes. We will determine the patients' clinical and pathological outcomes in the same way for the primary outcome measure. Based on the collected tumor information after surgery, ER, PR, HER2 and ki-67 will be used to divide breast cancers treated with NAC into 4 subtypes: luminal A (ER+, PR+, HER2-, and ki-67≤14%), luminal B (ER+, PR+, HER2- and ki-67>14%; ER+ and/or PR+, HER2+), HER2-overexpression (ER-, PR- and HER2+) and triple-negative (ER-, PR-, and HER2-). The ability of the SHAPE method to distinguish responders from non-responders will be compared between breast cancer subtypes using ROC analysis.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715958


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kibo Nam, PhD    215-955-6261    Kibo.Nam@jefferson.edu   
Principal Investigator: Kibo Nam, PhD         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Basak Dogan    214-645-9729    Basak.dogan@utsouthwestern.edu   
Sponsors and Collaborators
Kibo Nam
More Information
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Responsible Party: Kibo Nam, Principal Investigator, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04715958    
Other Study ID Numbers: 20F.259
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases