Stanford APBI Trial
Clinical Trial
Overview
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.
Does rTMS Induce Synaptic Plasticity?
The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer [11C]UCB-J to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on synaptic plasticity. UCB-J has been validated as a marker for synaptic density. We will use this tracer to examine if rTMS leads to changes in synaptic plasticity, specifically changes in synaptic density, in individuals receiving rTMS for MDD. If rTMS is proven effective for increasing synaptic plasticity, there is a significant potential of a new applicable treatment for a variety of diseases that affect brain physiology.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: [11C]UCB-J radiotracer
- device: PET-MR
Eligibility
Inclusion Criteria:
- 18-70 years in age
- U.S. Veteran
- Diagnosis of MDD
- On a stable medication regimen for at least two weeks prior to testing
- Stable social environment and housing to enable regular attendance at clinic visits
- Ability to undergo cognitive testing, clinical assessments, and PET/MR scans
- Stable medical health
- Will undergo rTMS treatment for MDD at the VA Palo Alto
- Able to complete a PET-MR scan without the use of sedation
Exclusion Criteria:
- Active substance use within three months of testing
- IQ < 70
- Major medical neurological illness or significant head trauma
- Pregnancy or breastfeeding
- Contraindication to MR scanning, including magnetic-resonance incompatible metal or
hardware including pacemakers, cochlear implants, and bullets near a critical organ
- Weight > 350 lbs or a large body habitus that MR scanner cannot accommodate
- History of or current claustrophobia
- Inability to comply with basic study requirements such as following directions and
punctuality
- Acute or unstable chronic medical illness that would affect participation or
compliance with study procedures, e.g. unstable angina
- Unstable psychiatric symptoms that precludes consistent participation in the study,
e.g. active current suicidal intent or plan, severe psychosis
- Inability to undergo PET/MR scan, e.g. claustrophobia, presence of ferromagnetic
objects in subject's body
Ages Eligible for Study
18 Years - 70 Years
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
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.