Clinical trial · Interventional
Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome. 2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies. The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used "off-label" (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D US grayscale plus quantitative VCEUS | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 2D US grayscale plus quantitative VCEUS
- description
- Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging: 1. prior to initiation of treatment (baseline); 2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); 3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); 4. at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.
- interventionNames
- Diagnostic Test: 2D US grayscale plus quantitative VCEUS
Primary outcomes (8)
- measure
- Tumor Volume Measure Using Grayscale US
- timeFrame
- Baseline (first visit)
- description
- Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients (age 19 years or older). 2. Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy. 3. Patients with signed informed consent. Exclusion Criteria: 1. Any history of prior radiation or chemotherapy for breast cancer. 2. Patients who only have non-measurable disease. 3. Patients who are medically unstable. 4. Patients with other primary cancers requiring systemic treatment. 5. Patients with cardiac shunts. 6. Patients with unstable cardiopulmonary conditions. 7. Patients with known pulmonary hypertension. 8. Patients with known hypersensitivity to any component of Definity (R) microbubble contrast. 9. Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
References
Publications (0)
Data not yet available