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Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 100 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "CT scans will be obtained with 1.25 mm thickness and will be acquired with free breathing as well as additional scans as needed for motion control or gating. 4DCT, MRI and PET imaging may be used to assist in determining motion estimation."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (2)

FL