Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT01588834
Eligibility Criteria:
Inclusion Criteria:
* Ages 40 - 55 years
* Considered premenopausal or peri-menopausal
* Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
* Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
* No proliferative benign lesions (e.g. fibroadenomas) identified
* Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
* MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
* No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
* Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)
Exclusion criteria:
* Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
* Prior diagnosis of bilateral breast cancer.
* Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
* Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
* Current breast symptoms
* Breast implants
* Known allergy to local anesthetic.
* History of bleeding complications from prior interventions
* Current use of anticoagulants (e.g., Coumadin or other blood thinners)
* Major medical condition
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT01588834
Study Brief:
Protocol Section:
NCT01588834