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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02324205
Eligibility Criteria:
Inclusion Criteria:
* Women aged 30 years or older (≥30 years old);
* Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound (U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry;
* Are able and willing to comply with study procedures;
* Have signed and dated the informed consent form;
* Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy.
Exclusion Criteria:
* Have been previously included in this study;
* Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging;
* Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during a DBT examination (or FFDM, if required);
* Have participated in (within the prior 30 days), another trial of an investigational product expected to interfere with study procedures or outcomes;
* Have breast implant(s);
* Have reconstructed breast(s).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT02324205
Study Brief:
Protocol Section:
NCT02324205