Visualization Tool for Investigation of Breast Lesions

NCT00934297 | Terminated

• 1 other identifier: 049-2009
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Lesions

Keywords

MRI visible breast lesions that are occult under ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Links

• Abstract

Study Officials

• Petrina Causer, MD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

CA (1)