Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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2D US grayscale plus quantitative VCEUS

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.

Group Type OTHER

2D US grayscale plus quantitative VCEUS

Intervention Type DIAGNOSTIC_TEST

This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.

Interventions

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2D US grayscale plus quantitative VCEUS

This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Definity VCEUS

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No