Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

January 3, 2018 updated by: Mark E. Lockhart, University of Alabama at Birmingham

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: 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.
Other Names:
  • Definity VCEUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Volume Measure Using Grayscale US
Time Frame: Baseline (first visit)
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.
Baseline (first visit)
VCEUS Perfusion Time to Peak
Time Frame: Baseline
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.
Baseline
Tumor Volume Measure Using Grayscale US
Time Frame: Week 2
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.
Week 2
Tumor Volume Measure Using Grayscale US
Time Frame: Week 4
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.
Week 4
Tumor Volume Measure Using Grayscale US
Time Frame: 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.
6 months
VCEUS Perfusion Time to Peak
Time Frame: Week 2
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.
Week 2
VCEUS Perfusion Time to Peak
Time Frame: Week 4
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.
Week 4
VCEUS Perfusion Time to Peak
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathology Residual Tumor
Time Frame: 6 months
Pathology residual tumor measured in millimeters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Mark E Lockhart, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R12-021
  • 115,576 (Other Identifier: fda)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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