Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 6
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: American Cancer Society, Inc.
• Last Updated: 2016-12-15

Criteria

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.