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.

Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • device: Genicular artery embolization (GAE)

Eligibility


Inclusion Criteria:

   1. Provide informed consent

   2. Age ≥ 40 years

   3. Moderate to severe knee pain (VAS >40 mm)

   4. Pain refractory to 3 months of conservative treatments, including at least one of the
   following:

      - a. Anti-inflammatory medications

      - b. Physical therapy

      - c. Intra-articular injections

   5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease

   6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).

   7. Ineligibility or refusal of surgical management.

   8. Local knee tenderness

Exclusion Criteria:

   1. Rheumatoid or infectious arthritis

   2. Advanced lower extremity atherosclerosis that would limit selective angiography

   3. Local knee infection

   4. Prior knee surgery (excluding arthroscopic/meniscal interventions)

   5. Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)

   6. Iodine allergy resulting in anaphylaxis

   7. Chronic renal insufficiency (serum creatinine >2 mg/dL)

   8. Life expectancy less than 6 months

Ages Eligible for Study

40 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrew C Picel, MD
650-736-6109
Not Recruiting

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.