Clinical trial NCT00934297: Visualization Tool for Investigation of Breast Lesions
Official title: Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Lesions
Keywords: MRI visible breast lesions that are occult under ultrasound
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Time of examination
Secondary outcomes:
measure: 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
timeFrame: Time of examination
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Petrina Causer, MD
role: PRINCIPAL_INVESTIGATOR
References: