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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT03684733
Eligibility Criteria:
Inclusion Criteria:
Cohort 1:
* Normal breast tissue in one or both breasts
* Aged \> 39.5 years
* ≤ 6 months between XRM and MRI examinations
Cohort 2:
* Genetically proven BRCA1 or 2 mutation carrier
* Age 39.5 - 50.5 years
* ≤ 6 months between XRM and MRI examinations
Cohort 3:
* Previous mantle radiotherapy
* Age 39.5 - 50.5 years
* ≤ 6 months between XRM and MRI examinations
Cohort 4:
* Radiologically healthy breast tissue as assessed by XRM
* Age 39.5 - 50.5 years
* Able to attend MRI screening within 6 weeks of XRM
Exclusion Criteria:
Cohort 1:
\- Treatment or medication between XRM and MRI examinations
Cohort 2:
* Previous breast cancer diagnosis and/or treatment
* Treatment or medication between XRM and MRI examinations
Cohort 3:
* Previous breast cancer diagnosis and/or treatment
* Treatment or medication between XRM and MRI examinations
Cohort 4:
* Previous breast cancer diagnosis and/or treatment
* MRI incompatible implants
* Claustrophobia
* Inability to tolerate a 40 minute MRI breast examination
* Patients with renal failure or problems with IV access
Sex:
FEMALE
Minimum Age:
39 Years
Maximum Age:
50 Years
Study:
NCT03684733
Study Brief:
Protocol Section:
NCT03684733