Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 1/28/2018 |
| Start Date: | June 2015 |
| End Date: | July 2016 |
A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy
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.
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.
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.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-934-4080
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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