Visualization Tool for Investigation of Breast Lesions

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00934297

Enrollment

Registered

2009-07-08

Start date

2009-07-31

Completion date

2011-07-31

Last updated

2011-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Lesions

Keywords

MRI visible breast lesions that are occult under ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 80 Years

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada

Outcome results