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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03771833
Eligibility Criteria:
Inclusion Criteria:
* attending a symptomatic breast care clinic at the study site
* have a palpable lump in the breast
* female sex
* 18 years or older
* able to provide informed consent
* not in any identified vulnerable group
Exclusion Criteria:
* unable to mount MARIA patient bed using provided 2-step
* unable to lie in the prone position for a period of up to 15 minutes
* patient who have undergone biopsy less than 5 days before the MARIA scan
* patient with implanted electronics
* patient with breast implants
* patients with nipple piercings (unless they are removed prior to the MARIA scan)
* breast size too small or too large to be suitable for both arrays
Further:
* participants with a large cyst or cysts that require draining at their clinical appointment will not be eligible for Arm 1, as the procedure to drain their cyst will change the appearance of the cyst from the imaging that they have done that day to the MARIA image obtained around 10 days later
* Arm 1 and 2 are mutually exclusive
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03771833
Study Brief:
Protocol Section:
NCT03771833