Visualization Tool for Investigation of Breast Lesions

This study has been terminated.
(The study was terminated as the PI left the institution.)
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00934297
First received: July 6, 2009
Last updated: July 27, 2011
Last verified: July 2011
  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
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

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934297

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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 April 15, 2014