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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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014