Molecular Breast Imaging in Women with Atypia and LCIS
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 1204-03
Sponsor Protocol Number: 1204-03
About this study
We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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:
Subjects will be excluded if:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Deborah Rhodes, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available