Visualization Tool for Investigation of Breast Lesions

Breast Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00934297
• Other study ID #: 049-2009
• Status: Terminated
• Phase: N/A
• First received: July 6, 2009
• Last updated: July 27, 2011
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Lesions

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Abstract