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:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT05968157
Eligibility Criteria:
Inclusion Criteria:
* Women who were identified as high risk on the retrospective study (dating from 2017-2025) using MIRAI will be recruited and consented for the prospective study
* Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study
* Following consent and enrollment in the study, a participant will subsequently receive the following:
1. These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
2. Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis.
* To be selected, a given record must include the following:
1. A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
2. Reports of all follow up screening and diagnostic studies documented on PACS.
3. Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR.
Exclusion Criteria:
* Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
* Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
* Pregnant patients because they do not routinely receive screening mammogram
* Adult male patients with breast cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT05968157
Study Brief:
Protocol Section:
NCT05968157