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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT04985032
Eligibility Criteria:
Inclusion Criteria:
1. Women 50 years or older
2. Low to intermediate grade DCIS or invasive ductal carcinoma
3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS
4. Well defined lumpectomy cavity on CT
5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS
6. Node negative
7. Unifocal lesion
8. ER and/or PR positive
9. HER-2 negative
10. BRCA negative
11. Lumpectomy cavity must be \< 30% of whole breast volume
Exclusion Criteria:
1. Lobular histology
2. Angiolymphatic invasion
3. Multiple foci of disease
4. Lymphovascular invasion
5. Active lupus or sarcoid
6. Distant metastases
7. Non-epithelial malignancies
8. Synchronous contralateral breast cancer
9. Grade 2 or higher oncoplastic surgery
10. Ipsilateral pacemaker
11. Ipsilateral breast implant
12. Neoadjuvant chemotherapy
13. Prior ipsilateral breast cancer or thoracic radiation
14. Poor breast integrity
15. Paget's Disease of the nipple
16. Pregnant patients
17. Severe cardiac, pulmonary, or liver diseases
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
100 Years
Study:
NCT04985032
Study Brief:
Protocol Section:
NCT04985032