Visualization Tool for Investigation of Breast Lesions
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Purpose
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.
| Condition |
|---|
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Breast Lesions |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions |
- 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 Frame: Time of examination ] [ Designated as safety issue: No ]
- 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 Frame: Time of examination ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: | Petrina Causer, MD | Sunnybrook Health Sciences Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Petrina Causer, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00934297 History of Changes |
| Other Study ID Numbers: | 049-2009 |
| Study First Received: | July 6, 2009 |
| Last Updated: | July 27, 2011 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
|
MRI visible breast lesions that are occult under ultrasound |
ClinicalTrials.gov processed this record on May 19, 2013