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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT03220893
Eligibility Criteria:
Inclusion Criteria:
* Patient is a consenting female age 40-75 years
* Patient is scheduled for routine screening DBT
* Patient is asymptomatic for breast disease
* Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (Breast Imaging Reporting and Data System \[BI-RADS\] c or d) within 24 months of enrollment
* Patient is able to participate fully in all aspects of the study (completing study visits and study data collection)
* Patient understands and signs the study informed consent
* Patient anticipates being able to return one year after study enrollment to complete the second round of screening
Exclusion Criteria:
* Patient is currently pregnant or plans to become pregnant during the course of the study
* Patient is currently lactating
* Patient has had a prior MBI
* Patient has had a prior whole breast ultrasound (WBUS) for screening, with either a hand-held ultrasound probe or automated system, within 12 months prior to study enrollment
* Patient has had a prior breast MRI
* Patient has had a prior contrast-enhanced mammogram (contrast enhanced spectral mammography \[CESM\] or contrast-enhanced digital mammography \[CEDM\])
* Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI
* Patient has had a breast biopsy within 3 months prior to study enrollment
* Patient has had breast surgery within 12 months prior to study enrollment
* Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (atypical ductal hyperplasia \[ADH\], atypical lobular hyperplasia \[ALH\], lobular carcinoma in situ \[LCIS\], papilloma, radial scar)
* Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane)
* Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03220893
Study Brief:
Protocol Section:
NCT03220893