Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
Stopped early · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01817374
- Run by
- University of Alabama at Birmingham
- People needed
- 6
- Starts
- 2015-06-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-01-26
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (age 19 years or older).
- Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy.
- Patients with signed informed consent.
You may not qualify if…
- Any history of prior radiation or chemotherapy for breast cancer.
- Patients who only have non-measurable disease.
- Patients who are medically unstable.
- Patients with other primary cancers requiring systemic treatment.
- Patients with cardiac shunts.
- Patients with unstable cardiopulmonary conditions.
- Patients with known pulmonary hypertension.
- Patients with known hypersensitivity to any component of Definity (R) microbubble contrast.
- Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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