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.
A Multi-Center Trial of the ProLung Test™
The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.
There are three Specific Aims of this study:
1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
3. Assess the safety and tolerability of the ProLung Test procedures.
Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Eligibility
Inclusion Criteria:
Subjects who meet all of the following criteria may be enrolled in this Study:
1. Subject is male or female, age 18 or older.
2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or
lesions suspicious for lung cancer.
3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the
largest nodule or lesion dimension identified from CT imaging.
4. Subject meets one or more of the following conditions:
- indicated for a tissue biopsy
- indicated for surgical resection of the lung
5. Subject must be able to receive a ProLung Test
- within 60 days of abnormal CT (Inclusion Criterion 2 & 3)
- within 60 days prior to the tissue biopsy or surgical resection (Inclusion
Criterion 4).
6. Subject is capable of understanding and agreeing to fulfill the requirements of this
Protocol.
7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
Exclusion Criteria
The following criteria will disqualify a subject from enrollment into this Study:
1. Subject has an implanted electronic device in the chest.
2. Subject receiving therapy for suspected chest infection such as fungal infection or
tuberculosis.
3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or
any cancer in which the Principal Investigator does not suspect metastatic disease to
the lung, who has 2 or more suspicious pulmonary nodules.
4. Subject has received an invasive medical or surgical procedure within the thoracic
cavity within 30 days prior to the ProLung Test or within the previous 14 days for a
bronchoscopic procedure.
5. Subject presents with an anomalous physical or anatomical condition that precludes
ProLung Test measurement.
6. Subject will have undergone unusually strenuous exercise within 24 hours.
7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced
heart failure, or a recent myocardial infarction, or other medical condition such as
severe morbid obesity that in the judgment of the Principal Investigator would make
him/her unsuitable for the Study.
Ages Eligible for Study
18 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
CCTO
650-498-7061
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.