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Low recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast perfusion and elastography arm | Experimental | Intravenous injection of microbubble contrast agent and elastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflutren lipid microsphere | Drug | Intravenous injection of 10 microL/kg once prior to ultrasound examination |
|
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of transient shear wave elastography . | The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers. | The participant will be followed up till the results of the biopsy, an expected average of 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberta A Jong, FRCPC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |