Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
This trial is active, not recruiting.
|Treatment||molecular breast imaging|
|Start date||September 2012|
|End date||June 2017|
|Trial size||12 participants|
|Trial identifier||NCT01806558, 12-004900|
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.
|Intervention model||single group assignment|
To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
time frame: 1 year
Female participants at least 40 years old.
- 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.
- 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
|Official title||Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions|
|Principal investigator||Michael K O'Connor, PhD, R-D|
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