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.

Rapid Acting Transcranial Magnetic Stimulation

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • device: Active TBS-DLPFC
  • device: Sham TBS-DLPFC

Eligibility


Inclusion Criteria:

   1. Male or Female, between the ages of 22 and 65 at the time of screening.

   2. Able to read, understand, and provide written, dated informed consent prior to
   screening.

   Proficiency in English sufficient to complete questionnaires / follow instructions
   during fMRI assessments. Stated willingness to comply with all study procedures,
   including availability for the duration of the study, and to communicate with study
   personnel about adverse events and other clinically important information.

   3. Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a
   Major Depressive Episode, according to the criteria defined in the Diagnosis and
   Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

   4. Medical records confirming a history of moderate to severe treatment-resistance as
   defined by a score of 7-14 on the Maudsley Staging Method (MSM 3).

   5. MADRS score of ≥20 at screening (Visit 1).

   6. TMS naive.

   7. Access to ongoing psychiatric care before and after completion of the study.

   8. Access to clinical rTMS after study completion.

   9. Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study
   enrollment and agree to continue this regimen throughout the study period.

10. In good general health, as evidenced by medical history.

11. For females of reproductive potential: use of highly effective contraception for at
   least 1 month prior to screening and agreement to use such a method during study
   participation.

12. Agreement to adhere to Lifestyle Considerations throughout study duration.

Lifestyle Considerations:

   - Abstain from becoming pregnant from the screening visit (Visit 1) until after the
   final study visit (Visit 13).

   - Continue usual intake patterns of caffeine- or xanthine-containing products (e.g.,
   coffee, tea, cola drinks, and chocolate) without significant change for the duration
   of the study.

   - Abstain from alcohol for at least 24 hours before the start of each MRI and TMS
   session.

   - Participants who use tobacco products will be informed that use will be allowed only
   in between intervention sessions.

Exclusion Criteria:

   1. Pregnancy

   2. Primary psychiatric condition other than MDD requiring treatment except stable
   comorbid anxiety disorder

   3. History of or current psychotic disorder or bipolar disorder

   4. Severe borderline personality disorder.

   5. Diagnosis of Intellectual Disability or Autism Spectrum Disorder

   6. Current moderate or severe substance use disorder or demonstrating signs of acute
   substance withdrawal

   7. Urine screening test positive for illicit substances

   8. Active suicidal ideation (defined as an MSSI > 8) or a suicide attempt (as defined by
   the C-SSRS) within the past one year

   9. Any history of ECT (greater than 8 sessions) without meeting responder criteria

10. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting
   antidepressant agent (i.e., ketamine or a course of ECT)

11. History of significant neurologic disease, including dementia, Parkinson's or
   Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple
   sclerosis, or history of significant head trauma

12. Untreated or insufficiently treated endocrine disorder.

13. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known
   brain lesion)

14. Contraindication to MRI (ferromagnetic metal in their body)

15. Treatment with an investigational drug or other intervention within the study period

16. Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)

17. Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS
   score.

18. Any other condition deemed by the PD to interfere with the study or increase risk to
   the participant

Ages Eligible for Study

22 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Romina Nejad, MSc
650-497-3933
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.