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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04994067
Eligibility Criteria:
Inclusion Criteria:
* Female gender
* Age ≥ 45
* cT1-2N0, \<3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive
* Suitable for breast conserving surgery
* No contraindication to radiation
* Mammogram within 6 months of planned procedure
* Fitness for lumpectomy under general anesthesia
* Planned to receive IORT
Exclusion criteria
* Known axillary lymph node positive breast cancer (negative biopsy not required)
* Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
* Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
* Patients undergoing neoadjuvant chemotherapy
* Pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04994067
Study Brief:
Protocol Section:
NCT04994067