Breast 3DUS ABUS System Comparison
ConditionBreast Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Patients who are scheduled for screening ABUS
Adults Patients who are scheduled for short term follow-up with ABUS.
Must be at least 18 years of age or older.
Must be proficient in English (reading/writing).
Disqualifiers
Patients with breast implants.
Patients with contraindication for ABUS.
Patients who cannot tolerate ABUS.
Trial design
Design model
Single group
Treatments tested in this trial
3D Ultrasound Image Acquisition
DeviceA custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients at Risk of Breast CancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Breast Images
Images of the breast anatomy will be compared to standard of care imaging.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov