Trial | NCT02067884  Report issue

Title

Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    perflutren protein-type a microspheres ...

  • Study Participants

    34
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.
PRIMARY OBJECTIVES:

I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).

II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).

III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.

IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).

SECONDARY OBJECTIVES:

I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.

II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.

OUTLINE:

Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Study Started
Dec 19
2013
Primary Completion
Sep 25
2016
Study Completion
Sep 25
2016
Last Update
Jan 25
2019

Procedure dynamic contrast-enhanced ultrasound imaging

Undergo CEUS

  • Other names: DCE-USI

Procedure shear wave elastography

Undergo SWE

  • Other names: SWE

Drug Definity, (Lipid Microspheres) Intravenous Suspension

Participant will receive contrast agent by intravenous administration

  • Other names: Perflutren Lipid Microsphere

Device Philips Shear Wave Elastography

Equipment used for SWE

  • Other names: Shear Wave Elastography

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.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted