Status:
COMPLETED
Molecular Breast Imaging in Women With Atypia and LCIS
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Atypical Lobular Hyperplasia
Atypical Ductal Hyperplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 lobul...
Detailed Description
Management of atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), and lobular carcinoma in situ (LCIS) diagnosed by breast needle core needle biopsy is controversial. Current practi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00620087
Start Date
August 1 2003
End Date
July 1 2015
Last Update
October 10 2016
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905