Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

NCT01817374 | Terminated Results

• 2 other identifiers: R12-021115,576
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Definity; Ultrasound

Outcome Measures

Primary Outcomes (8)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Pathology Residual Tumor

  6 months

Study Arms (1)

2D US grayscale plus quantitative VCEUS

OTHER

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

Interventions

2D US grayscale plus quantitative VCEUS 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.

Also known as: Definity VCEUS

2D US grayscale plus quantitative VCEUS

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Marianne Vetrano
• Organization: UAB Radiology Research

mvetrano@uabmc.edu

205-934-4080

Study Officials

• Mark E Lockhart, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 25, 2013
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 26, 2018
• Results First Posted: November 21, 2017

Record last verified: 2018-01

Locations

US (1)