Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).
Stanford is currently accepting patients for this trial.
Intervention(s):
- device: Ablation
Eligibility
Inclusion Criteria:
1. Subjects with paroxysmal atrial fibrillation who have had two or more spontaneously
terminating episodes of atrial fibrillation, that last longer than 30 seconds and
shorter than 7 days, in the nine months prior to enrollment. At least one episode must
be documented with EKG, TTM, Holter monitor, or telemetry.
2. Failure of at least one Class I - IV anti-arrhythmic drug (AAD) for PAF as evidenced
by recurrent symptomatic PAF, or intolerable side effects due to AADs. AADs are
defined in Appendix B.
3. Signed informed consent.
4. Age 18 years or older
5. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements.
Exclusion Criteria:
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible
or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Atrial fibrillation episodes that last less than 7 days and are terminated by
cardioversion.
4. Previous valvular cardiac surgery procedure.
5. Cardiac artery bypass graft procedure within the previous 180 days.
6. Previous septal defect repair.
7. Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
8. Coronary PTCA/stenting within the previous 180 days.
9. Documented left atrial thrombus on ultrasound imaging (TEE).
10. Documented history of a thrombo-embolic event within the previous 365 days.
11. Diagnosed atrial myxoma.
12. Presence of an implanted ICD.
13. Presence of permanent pacing leads.
14. Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any
other disease or malfunction of the lungs or respiratory system with chronic symptoms.
15. Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this study.
16. Women who are pregnant.
17. Acute illness or active infection at time of index procedure documented by either
pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3) for
which antibiotics have been or will be prescribed.
18. Creatinine > 2.5 mg/dl (or > 221 µmol/L).
19. Unstable angina.
20. Myocardial infarction within the previous 60 days.
21. Left ventricular ejection fraction less than 40%
22. History of blood clotting or bleeding abnormalities.
23. Contraindication to anticoagulation medications.
24. Contraindication to computed tomography or magnetic resonance imaging procedures.
25. Life expectancy less than 1 year.
26. Enrollment in another investigational study.
27. Uncontrolled heart failure (NYHA class III or IV heart failure).
28. Presence of an intramural thrombus, tumor, or other abnormality that precludes
catheter introduction or positioning.
29. Presence of a condition that precludes vascular access.
30. Left atrial size ≥ 50mm.
31. INR greater than 3.0 within 24 hours of procedure.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Amin Al-Ahmad
6507237111
I'm interested
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.