Breast Cancer
Conditions
Keywords
Breast cancer, molecular breast imaging, breast, breast lesion
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.
Interventions
PROCEDUREMolecular Breast Imaging
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: 1. 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. 2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size. 3. Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.
Exclusion criteria
1. Are unable to understand and sign the consent form 2. Are pregnant or lactating 3. Are physically unable to sit upright and still for 40 minutes 4. Have undergone bilateral mastectomy 5. Are not scheduled to undergo conventional ultrasound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality. | 1 year | Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI. |
Countries
United States
Outcome results
None listed