Breast 3DUS ABUS System Comparison
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D Ultrasound Image Acquisition.
- Who it may be relevant to
- Registry conditions: Breast Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
Overview
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.
Interventions
- Device 3D Ultrasound Image Acquisition
A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.
Primary outcome measures
- Breast Images [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- Patients with breast implants.
- Patients with contraindication for ABUS.
- Patients who cannot tolerate ABUS.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 1 center
- St. Joseph's Hospital — London
Identifiers
NCT: NCT06118996 · 14144