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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT02522468
Eligibility Criteria:
Inclusion Criteria:
* Female
* 20 to 99 years of age
* Breast lesion necessitating image-guided excision
* Unifocal disease
* Breast-conservation candidate
* Biopsy-proven malignant breast lesion including by not limited to invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ
* Signed written informed consent document by the subject and/or a LAR
Exclusion Criteria:
* Male
* Multifocal or multicentric disease
* Receiving neoadjuvant chemotherapy
* Pregnant or breastfeeding
* Locally advanced disease
* Breast conservation contraindication such as inability to receive whole breast radiation therapy, inability to tolerate localization procedure, inability to lay flat or prone for radiation, and undesirable tumor to breast ratio
* Prior breast cancer on ipsilateral side
* Unable or unwilling to adhere to post-localization instructions (e.g. timely seed removal)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
99 Years
Study:
NCT02522468
Study Brief:
Protocol Section:
NCT02522468