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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT02040493
Eligibility Criteria:
General Inclusion Criteria
1. Age \> 45 years
2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification)
3. Invasive ductal carcinoma and / or DCIS
Intra-operative Inclusion Criteria
1. Negative sentinel node assessment
2. Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound
Post procedure Inclusion Criteria 1. Negative microscopic surgical margins\*\*
\*\*If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis.
General Exclusion Criteria
1. Scleroderma, systemic sclerosis and active lupus
2. Participation in an investigational drug or device study
3. Previous ipsilateral radiation to the thorax or breast
Intra-operative Exclusion Criteria
1. Intra-operative positive sentinel lymph node biopsy
2. Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image)
3. Skin spacing less than 1-cm via intraOp ultrasound.
4. A cavity size that is not appropriate for a 40 -70 cc balloon.
5. Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT02040493
Study Brief:
Protocol Section:
NCT02040493