Diagnostic Study of Early Breast Cancer Using Ultrasound

Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391039

Enrollment

Registered

2011-07-11

Start date

2011-09-30

Completion date

2015-07-31

Last updated

2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductal Carcinoma In-situ

Keywords

Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography

Brief summary

This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

Detailed description

Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.

Interventions

DRUGPerflutren lipid microsphere

Intravenous injection of 10 microL/kg once prior to ultrasound examination

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study. * At least 18 years of age

Exclusion criteria

* Pregnant or possibly pregnant or breast feeding * Unable to provide informed consent * Drug or multiple allergies * Known cardiac shunts * Known cardiac or chronic pulmonary disease * Hypersensitivity to perflutren

Design outcomes

Primary

Measure	Time frame
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.	The participant will be followed up till the results of the biopsy, an expected average of 3 months.

Secondary

Measure	Time frame	Description
Measurement of transient shear wave elastography .	The participant will be followed up till the results of the biopsy, an expected average of 3 months.	The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026