Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: 2D US grayscale plus quantitative VCEUS

• Registration Number: NCT01817374
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-25
• Study Start: 2015-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-06-08
• Results First Submitted QC: 2017-10-19
• Results First Posted: 2017-11-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2D US grayscale plus quantitative VCEUS	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.

Primary Outcome Measures

Name	Time	Method
Tumor Volume Measure Using Grayscale US	6 months	Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
VCEUS Perfusion Time to Peak	6 months	Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.

Secondary Outcome Measures

Name	Time	Method
Pathology Residual Tumor	6 months	Pathology residual tumor measured in millimeters

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States