Clinical trial · Interventional
SHAPE Neoadjuvant Chemotherapy Response
Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Locally Advanced Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Perflutren Lipid Microspheres | Drug | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CEUS, Definity)
- description
- Patients undergo CEUS and receive perflutren lipid microspheres 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
- interventionNames
- Procedure: Contrast-Enhanced Ultrasound
- Drug: Perflutren Lipid Microspheres
- Procedure: Ultrasound
Primary outcomes (3)
- measure
- Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
- timeFrame
- Up to study completion (48 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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: * 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
References
Publications (0)
Data not yet available