An interventional study of Perflutren lipid microsphere in Ductal Carcinoma In-situ, sponsored by Sunnybrook Health Sciences Centre. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Diagnostic
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.
363 studies on the registry are indexed under Carcinoma in Situ; 47 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 272 interventional studies indexed under Carcinoma in Situ.
Browse Carcinoma in Situ studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous injection of microbubble contrast agent and elastography
Drug: Perflutren lipid microsphere
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Also known as: Definity
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
Time frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Measurement of transient shear wave elastography .
The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.
Time frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sunnybrook Health Sciences Centre