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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT03196635
Eligibility Criteria:
Inclusion Criteria:
* Are women aged 40 years or older;
* Are asymptomatic and scheduled for FFDM screening mammography;
* Have left and right breasts;
* Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
* Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
* Are able and willing to comply with study procedures; and
* Are able and willing to provide written informed consent to participate.
Exclusion Criteria:
* Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;
* Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
* Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
* Are currently lactating; or
* Have breast implants.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT03196635
Study Brief:
Protocol Section:
NCT03196635