Status:
COMPLETED
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01806558
Start Date
September 1 2012
End Date
June 1 2017
Last Update
July 3 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905