NCT02067884

Brief Summary

This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2016

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

February 4, 2014

Last Update Submit

January 23, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Model predicted treatment response for CEUS and SWE

    Weighted Kappa will be used to assess the agreement.

    Up to 1 year

  • Pathologically determined treatment response for CEUS and SWE

    Weighted Kappa will be used to assess the agreement.

    Up to 1 year

Secondary Outcomes (2)

  • Treatment response predicted by novel ultrasound techniques

    Up to 1 year

  • Treatment response predicted by CE MRI

    Up to 1 year

Study Arms (1)

Diagnostic (CEUS, SWE)

EXPERIMENTAL

Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Procedure: dynamic contrast-enhanced ultrasound imagingProcedure: shear wave elastographyDrug: Definity, (Lipid Microspheres) Intravenous SuspensionDevice: Philips Shear Wave Elastography

Interventions

dynamic contrast-enhanced ultrasound imagingPROCEDURE

Undergo CEUS

Also known as: DCE-USI
Diagnostic (CEUS, SWE)
shear wave elastographyPROCEDURE

Undergo SWE

Also known as: SWE
Diagnostic (CEUS, SWE)
Definity, (Lipid Microspheres) Intravenous SuspensionDRUG

Participant will receive contrast agent by intravenous administration

Also known as: Perflutren Lipid Microsphere
Diagnostic (CEUS, SWE)
Philips Shear Wave ElastographyDEVICE

Equipment used for SWE

Also known as: Shear Wave Elastography
Diagnostic (CEUS, SWE)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with histologically confirmed breast cancer (by core needle biopsy)
  • Women with \>= 2 cm clinically or radiologically measureable breast cancer
  • Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
  • Women competent to sign study specific written Informed Consent
  • Women willing to comply with protocol requirements

You may not qualify if:

  • Women who are pregnant
  • Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
  • Women who have had a prior history of breast cancer in the same breast
  • Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
  • Women who cannot consent for themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Linda Hovanessian-Larsen

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 20, 2014

Study Start

December 19, 2013

Primary Completion

September 25, 2016

Study Completion

September 25, 2016

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

US(1)