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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT01806558
Eligibility Criteria:
Inclusion Criteria:
* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:
1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound.
2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size.
3. Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.
Exclusion Criteria:
1. Are unable to understand and sign the consent form
2. Are pregnant or lactating
3. Are physically unable to sit upright and still for 40 minutes
4. Have undergone bilateral mastectomy
5. Are not scheduled to undergo conventional ultrasound
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT01806558
Study Brief:
Protocol Section:
NCT01806558