Molecular Breast Imaging in Women With Atypia and LCIS
Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma in Situ
About this trial
This is an interventional diagnostic trial for Atypical Lobular Hyperplasia focused on measuring Atypical lobular hyperplasia, Atypical ductal hyperplasia, Lobular carcinoma in situ, Molecular Breast Imaging
Eligibility Criteria
Inclusion Criteria for Surveillance Arm:
- Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist.
Inclusion Criteria for Diagnostic Arm:
- Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist.
Exclusion Criteria:
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes
- They are younger than 18 years of age.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Other
Other
Diagnostic Arm
Surveillance arm
Women with core-biopsy proven atypia, LCIS, or radial scar who have not yet undergone surgical excision were enrolled in the diagnostic arm. A molecular breast imaging study will be obtained.
Women with a diagnosis of ADH, ALH, or LCIS within the past 5 years were enrolled in the surveillance arm. A molecular breast imaging study was done at enrollment (Year 0) and repeated at Yer 2 and Year 4. Patients continued with routine screening mammography during this time period.