Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01817374
• Other study ID #: R12-021
• Secondary ID: 115,576
• Status: Terminated
• Phase: N/A
• First received: March 7, 2013
• Last updated: January 3, 2018
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (first visit)
Primary	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.	Baseline
Primary	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.	Week 2
Primary	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.	Week 4
Primary	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.	6 months
Primary	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.	Week 2
Primary	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.	Week 4
Primary	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.	6 months
Secondary	Pathology Residual Tumor	Pathology residual tumor measured in millimeters	6 months