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The study was terminated as the PI left the institution.
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Magnetic resonance imaging (MRI) is commonly used for the detection of breast lesions in genetically high-risk women due to its high sensitivity. As non-cancerous conditions including normal changes due to a woman's menstrual cycle may have the appearance of cancer on MR images, a biopsy (generally performed under ultrasound-guidance) of the suspicious mass is required for definitive diagnosis. However, only a limited percentage of MRI-visible lesions are also visible on ultrasound (US). Even if found, it is often unclear whether the lesion identified on US corresponds to the MRI-detected lesion in question. The investigators have developed a visualization tool to assist the visualization of MRI-detected lesions in US-guided procedures (e.g., biopsy). This tool provides a simultaneous display of the previously acquired MRI data alongside real-time US images. The investigators propose a pilot study to assess the usefulness of this tool in identifying MRI-detected lesions using real-time US-guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot group | Real-time US imaging with simultaneous display of dynamically corresponding MR images (from a previous MRI screening) will be used to re-locate the lesion previously reported as occult under a second-look ultrasound screening. |
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| Measure | Description | Time Frame |
|---|---|---|
| Target identification success: this outcome measure is a 'yes/no' outcome, indicating whether or not an MRI-detected lesion could be successfully visualized using US-guidance in the supplemental US exam | Time of examination |
| Measure | Description | Time Frame |
|---|---|---|
| Confidence scale for lesion visualization This is a 5-point scale: 1 - very low confidence; 2 - low confidence; 3 - ambiguous; 4 - confident; 5 - very confident | Time of examination |
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Inclusion Criteria:
Exclusion Criteria:
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Patients clinically suspicious for breast cancer will undergo the standard bilateral MRI protocol, with the patient in the prone position and both breasts immobilized. Patients with a BIRADS reading of 4 or 5 based on the initial MRI are called back for a second-look US examination to determine if the lesion can be found using US imaging. If the lesion is occult to US during this second-look examination, the radiologist may recommend a follow-up high-resolution unilateral MRI to further characterize the lesion.
For this feasibility study, 10 patients with MRI-identified lesions that cannot be visualized under the second-look ultrasound examination, and who will undergo the recommended unilateral MRI follow-up will be asked to participate in our research study.
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| Name | Affiliation | Role |
|---|---|---|
| Petrina Causer, MD | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
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