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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03842358
Eligibility Criteria:
Inclusion Criteria:
* Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3\*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration
\*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).
* Willing and able to provide informed consent
Exclusion Criteria:
* Lesions located in the darkly pigmented nipple-areolar complex area
* Subjects with breast implants
* Abnormality in the mirror image location of the contralateral breast.
* Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy
* Previous breast irradiation of the mirror image location of the contralateral breast
* Lesions located at previous biopsy sites when biopsy occurred within the last six months.
* Pregnancy
* Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03842358
Study Brief:
Protocol Section:
NCT03842358