Clinical trial NCT01817374: Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
Official title: A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Definity
Ultrasound
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-03-25
Enrollment: 6
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Tumor Volume Measure Using Grayscale US
timeFrame: Baseline (first visit)
measure: VCEUS Perfusion Time to Peak
timeFrame: Baseline
measure: Tumor Volume Measure Using Grayscale US
timeFrame: Week 2
measure: Tumor Volume Measure Using Grayscale US
timeFrame: Week 4
measure: Tumor Volume Measure Using Grayscale US
timeFrame: 6 months
measure: VCEUS Perfusion Time to Peak
timeFrame: Week 2
measure: VCEUS Perfusion Time to Peak
timeFrame: Week 4
measure: VCEUS Perfusion Time to Peak
timeFrame: 6 months
Secondary outcomes:
measure: Pathology Residual Tumor
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark E Lockhart, MD
role: PRINCIPAL_INVESTIGATOR
References: