Visualization Tool for Investigation of Breast Lesions

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions

Conditions
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Breast Lesions

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: US-visible lesion. Any contraindications to MRI (e.g., pacemakers, metal implants). Any contraindications to US imaging. Pregnancy. Claustrophobia. Inability to lie still for 45 minutes-1 hour. In excess of 250 pounds. Incapability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI visible breast lesions that are occult under ultrasound