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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT05246735
Eligibility Criteria:
HEALTHY VOLUNTEERS
Inclusion Criteria:
1. Female, ≥20 years old
2. Breast size and epithelial integrity adequate to allow NIR imaging exams.
3. Ability to provide written informed consent
4. No serious associated psychiatric illnesses.
Exclusion Criteria:
1. Absolute or relative contraindication to MRI:
1. the presence of an electronic implant, such as a pacemaker
2. the presence of a metal implant, such as an aneurysm clip
3. claustrophobia
4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy
WOMEN WITH BREAST ABNORMALITIES
Inclusion:
1. Female, ≥ 20 years old.
2. Breast size and epithelial integrity adequate to allow NIR imaging exams.
3. Ability to provide written informed consent.
4. No serious associated psychiatric illnesses.
5. A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination.
Exclusion:
1. Absolute or relative contraindication to MRI:
1. the presence of an electronic implant, such as a pacemaker
2. the presence of a metal implant, such as an aneurysm clip
3. claustrophobia
4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy
3. A history of allergy to iodides
4. A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of NIR/MR imaging.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT05246735
Study Brief:
Protocol Section:
NCT05246735