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Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2D US grayscale plus quantitative VCEUS
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Definity, Ultrasound

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

2D US grayscale plus quantitative VCEUS

Arm Description

Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging: prior to initiation of treatment (baseline); at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); 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.

Outcomes

Primary Outcome Measures

Tumor Volume Measure Using Grayscale US
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
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.
Tumor Volume Measure Using Grayscale US
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.
Tumor Volume Measure Using Grayscale US
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.
Tumor Volume Measure Using Grayscale US
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
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.
VCEUS Perfusion Time to Peak
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.
VCEUS Perfusion Time to Peak
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

Pathology Residual Tumor
Pathology residual tumor measured in millimeters

Full Information

First Posted
March 7, 2013
Last Updated
January 3, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01817374
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Definity, Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D US grayscale plus quantitative VCEUS
Arm Type
Other
Arm Description
Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging: prior to initiation of treatment (baseline); at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
2D US grayscale plus quantitative VCEUS
Other Intervention Name(s)
Definity VCEUS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor Volume Measure Using Grayscale US
Description
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.
Time Frame
Baseline (first visit)
Title
VCEUS Perfusion Time to Peak
Description
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.
Time Frame
Baseline
Title
Tumor Volume Measure Using Grayscale US
Description
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.
Time Frame
Week 2
Title
Tumor Volume Measure Using Grayscale US
Description
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.
Time Frame
Week 4
Title
Tumor Volume Measure Using Grayscale US
Description
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.
Time Frame
6 months
Title
VCEUS Perfusion Time to Peak
Description
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.
Time Frame
Week 2
Title
VCEUS Perfusion Time to Peak
Description
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.
Time Frame
Week 4
Title
VCEUS Perfusion Time to Peak
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pathology Residual Tumor
Description
Pathology residual tumor measured in millimeters
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (age 19 years or older). Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy. Patients with signed informed consent. Exclusion Criteria: Any history of prior radiation or chemotherapy for breast cancer. Patients who only have non-measurable disease. Patients who are medically unstable. Patients with other primary cancers requiring systemic treatment. Patients with cardiac shunts. Patients with unstable cardiopulmonary conditions. Patients with known pulmonary hypertension. Patients with known hypersensitivity to any component of Definity (R) microbubble contrast. Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E Lockhart, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

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