Visualization Tool for Investigation of Breast Lesions

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Breast Lesions

Study type: Observational

Funder types: Other

Identifiers

NCT00934297

049-2009

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Pilot group

Description:

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.