NCT01806558
Completed
Not Applicable
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:
- •Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound.
- •Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size.
- •Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.
Exclusion Criteria
- •Are unable to understand and sign the consent form
- •Are pregnant or lactating
- •Are physically unable to sit upright and still for 40 minutes
- •Have undergone bilateral mastectomy
- •Are not scheduled to undergo conventional ultrasound
Outcomes
Primary Outcomes
To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
Time Frame: 1 year
Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.
Study Sites (1)
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