Trial Information
Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome 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
Outcome Time Frame:
Time of examination
Safety Issue:
No
Principal Investigator
Petrina Causer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sunnybrook Health Sciences Center
Authority:
Canada: Ethics Review Committee
Study ID:
049-2009
NCT ID:
NCT00934297
Start Date:
July 2009
Completion Date:
July 2011
Related Keywords:
- Breast Lesions
- MRI visible breast lesions that are occult under ultrasound