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


Phase 4
19 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

VCEUS Quantitative Response vs grayscale US

Outcome Description:

Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale US, utilizing final surgical pathology and clinical outcome as reference standards. Specifically, changes in peak signal intensity and area under the curve will be compared with co-temporal changes in volume on grayscale US.

Outcome Time Frame:

Post neoadjuvant therapy (aproximately 2-3 months after start of treatment)

Safety Issue:

No

Principal Investigator

Heidi R Umphrey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

R12-021

NCT ID:

NCT01817374

Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Definity
  • Ultrasound
  • Breast Neoplasms

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300