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NCT04715958

SHAPE Neoadjuvant Chemotherapy Response

Active, Not Recruiting
PHASE2Ages 21+InterventionalDiagnostic
Kibo Nam
~122 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Contrast-Enhanced UltrasoundPerflutren Lipid MicrospheresUltrasound

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
Measured over Up to study completion (48 months)
+2 more outcomes measured

Conditions

Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

3 sites across 3 states
Minnesota1
Pennsylvania1
Texas1

Study leadership

  • Kibo Nam, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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

What this trial measures

  • Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)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.

  • Prediction of the patients' clinical and pathological responseUp 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.

  • The ability of the SHAPE method to distinguish responders from non-respondersUp 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.