Intra-Operative Radiation Registry
Recruiting · NCT04994067 · Observational (researchers observe without assigning treatment) · Lead sponsor: Albert Einstein College of Medicine
View the official record on ClinicalTrials.gov →What this trial is about
This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Montefiore Medical Center - Moses Campus - The Bronx, New York, United States